Clinical Trials List
Protocol NumberPDX-017
NCT Number(ClinicalTrials.gov Identfier)NCT01420679
2012-06-30 - 2019-06-30
Phase III
Terminated8
ICD-10C84.40
Peripheral T-cell lymphoma, not classified, unspecified site
A Multi-center, Randomized, Phase 3 Study of Sequential Pralatrexate Versus Observation in Patients with Previously Undiagnosed Peripheral T-cell Lymphoma Who Have Achieved an Objective Response Following Initial Treatment with CHOP-based Chemotherapy
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Sponsor
Allos Therapeutics, Inc.
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Shang-Wen Chen Division of Hematology & Oncology
- 曹朝榮 Division of Hematology & Oncology
- Shang-Hung Chen Division of Hematology & Oncology
- 陳彥勳 Division of Hematology & Oncology
- 黃文聰 Division of Hematology & Oncology
- 陳威宇 Division of Hematology & Oncology
- 陳昭勳 Division of Hematology & Oncology
- 林正耀 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Chieh-Lin Teng Division of Hematology & Oncology
- 楊陽生 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Principal Investigator
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Shang-Yin Wu Division of Hematology & Oncology
- Ya-Ping Chen Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Li-Yuan Bai Division of Hematology & Oncology
- Yu-Min Liao Division of Hematology & Oncology
- 林柏翰 Division of Hematology & Oncology
- Su-Peng Yeh Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
Previously Undiagnosed Peripheral T-cell Lymphoma
Objectives
Primary
• Determine the efficacy of pralatrexate compared to observation when administered to
patients with previously undiagnosed peripheral T-cell lymphoma (PTCL) who have
achieved an objective response after completing at least 6 cycles of cyclophosphamide,
doxorubicin, vincristine, and prednisone (CHOP)-based treatment.
Secondary
• Determine the safety of pralatrexate when administered following a course of
CHOP-based treatment to patients with previously undiagnosed PTCL.
Test Drug
Pralatrexate
Active Ingredient
Pralatrexate
Dosage Form
靜脈注射劑
Dosage
20
Endpoints
Primary
• Progression-free survival (PFS) and overall survival (OS)
Secondary
• Objective response (complete response [CR] or partial response [PR]) to pralatrexate
versus observation
• Progression-free survival (PFS) and overall survival (OS)
Secondary
• Objective response (complete response [CR] or partial response [PR]) to pralatrexate
versus observation
Inclution Criteria
1. Patient’s PTCL histology has been confirmed as one of the following by an independent
pathology reviewer, using the Revised European American Lymphoma (REAL) World
Health Organization (WHO) disease classification:
a. T/natural killer (NK)-cell leukemia/lymphoma
b. Adult T-cell lymphoma/leukemia (human T-cell leukemia virus [HTLV] 1+)
c. Angioimmunoblastic T-cell lymphoma
d. Anaplastic large cell lymphoma (ALCL), primary systemic type, excluding anaplastic
lymphoma kinase positive (ALK+) with International Prognostic Index (IPI) score
< 2 at initial diagnosis and CR after completion of CHOP-based therapy
e. PTCL-unspecified
f. Enteropathy-type intestinal lymphoma
g. Hepatosplenic T-cell lymphoma
h. Subcutaneous panniculitis T-cell lymphoma
i. Transformed mycosis fungoides
j. Extranodal T/NK-cell lymphoma nasal or nasal type
k. Primary cutaneous gamma-delta T-cell lymphoma
l. Primary cutaneous CD8+ aggressive epidermic cytotoxic T-cell lymphoma
2. Documentation that the patient has completed at least 6 cycles of CHOP-based therapy,
including:
a. CHOP 21
b. CHOP 14
c. CHOEP
d. Other CHOP variants: includes all 4 components of CHOP represented, with
substitution allowed for any 1 component with a drug of the same mechanism of
action (eg, variant anthracyclines). Additional components to CHOP are allowed,
with the exception of alemtuzumab; rituximab may be combined with CHOP
provided that it is not given within 3 cycles of randomization.
3. Patient has achieved a CR or PR per investigator’s assessment following completion of
CHOP-based therapy and has had a radiological assessment within 21 days prior to
randomization.
4. ≥ 18 years of age.
5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
6. Adequate hematological, hepatic, and renal function as defined by:
a. Absolute neutrophil count (ANC) ≥ 1000/µL
b. Platelet count ≥ 100,000/µL
c. Total bilirubin ≤ 1.5 mg/dL
d. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × upper
limit of normal (ULN), (AST/ALT < 5 × ULN if documented hepatic involvement
with lymphoma). All patients with hepatitis B virus (HBV)-positive serology must
have liver function tests within the above parameters.
e. Creatinine ≤ 1.5 mg/dL (if the patient’s creatinine is > 1.5 mg/dL, then the calculated
creatinine clearance must be ≥ 50 mL/min).
7. Females of childbearing potential (ie, excluding patients who are postmenopausal for at
least 1 year [> 12 months since last menses] or are surgically sterilized) must:
a. Have a negative serum pregnancy test within 14 days prior to randomization and
b. Agree to practice a medically acceptable contraceptive regimen from study treatment
initiation until at least 30 days after the last administration of pralatrexate.
8. Males who are sexually active, including those with a pregnant partner, must agree to
practice a medically acceptable barrier method contraceptive regimen (eg, condoms)
while receiving pralatrexate and for 90 days after the last administration of pralatrexate.
9. Patient has given written informed consent (IC).
pathology reviewer, using the Revised European American Lymphoma (REAL) World
Health Organization (WHO) disease classification:
a. T/natural killer (NK)-cell leukemia/lymphoma
b. Adult T-cell lymphoma/leukemia (human T-cell leukemia virus [HTLV] 1+)
c. Angioimmunoblastic T-cell lymphoma
d. Anaplastic large cell lymphoma (ALCL), primary systemic type, excluding anaplastic
lymphoma kinase positive (ALK+) with International Prognostic Index (IPI) score
< 2 at initial diagnosis and CR after completion of CHOP-based therapy
e. PTCL-unspecified
f. Enteropathy-type intestinal lymphoma
g. Hepatosplenic T-cell lymphoma
h. Subcutaneous panniculitis T-cell lymphoma
i. Transformed mycosis fungoides
j. Extranodal T/NK-cell lymphoma nasal or nasal type
k. Primary cutaneous gamma-delta T-cell lymphoma
l. Primary cutaneous CD8+ aggressive epidermic cytotoxic T-cell lymphoma
2. Documentation that the patient has completed at least 6 cycles of CHOP-based therapy,
including:
a. CHOP 21
b. CHOP 14
c. CHOEP
d. Other CHOP variants: includes all 4 components of CHOP represented, with
substitution allowed for any 1 component with a drug of the same mechanism of
action (eg, variant anthracyclines). Additional components to CHOP are allowed,
with the exception of alemtuzumab; rituximab may be combined with CHOP
provided that it is not given within 3 cycles of randomization.
3. Patient has achieved a CR or PR per investigator’s assessment following completion of
CHOP-based therapy and has had a radiological assessment within 21 days prior to
randomization.
4. ≥ 18 years of age.
5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
6. Adequate hematological, hepatic, and renal function as defined by:
a. Absolute neutrophil count (ANC) ≥ 1000/µL
b. Platelet count ≥ 100,000/µL
c. Total bilirubin ≤ 1.5 mg/dL
d. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × upper
limit of normal (ULN), (AST/ALT < 5 × ULN if documented hepatic involvement
with lymphoma). All patients with hepatitis B virus (HBV)-positive serology must
have liver function tests within the above parameters.
e. Creatinine ≤ 1.5 mg/dL (if the patient’s creatinine is > 1.5 mg/dL, then the calculated
creatinine clearance must be ≥ 50 mL/min).
7. Females of childbearing potential (ie, excluding patients who are postmenopausal for at
least 1 year [> 12 months since last menses] or are surgically sterilized) must:
a. Have a negative serum pregnancy test within 14 days prior to randomization and
b. Agree to practice a medically acceptable contraceptive regimen from study treatment
initiation until at least 30 days after the last administration of pralatrexate.
8. Males who are sexually active, including those with a pregnant partner, must agree to
practice a medically acceptable barrier method contraceptive regimen (eg, condoms)
while receiving pralatrexate and for 90 days after the last administration of pralatrexate.
9. Patient has given written informed consent (IC).
Exclusion Criteria
1. Patient has:
a. Precursor T/NK neoplasms
b. ALCL (ALK+) with IPI score < 2 at initial diagnosis and CR after completion of
CHOP-based therapy
c. T-cell prolymphocytic leukemia (T-PLL)
d. T-cell large granular lymphocytic leukemia
e. Mycosis fungoides, other than transformed mycosis fungoides
f. Sézary syndrome
g. Primary cutaneous CD30+ disorders: ALCL and lymphomatoid papulosis
2. If there is a history of prior malignancies other than those exceptions listed below, the
patient must be disease-free for ≥ 5 years. Patients with the following prior malignancies
less than 5 years before study entry may still be enrolled if they have received treatment
resulting in complete resolution of the cancer and currently have no clinical, radiologic,
or laboratory evidence of active or recurrent disease.
a. Non-melanoma skin cancer
b. Carcinoma in situ of the cervix
c. Localized prostate cancer
d. Localized thyroid cancer
3. Patient has received prior treatment (chemotherapy or radiation) for PTCL, other than a
single allowed CHOP regimen, with the exception of:
a. Patients with nasal NK lymphoma are permitted to have received local radiation
therapy no less than 4 weeks prior to randomization.
b. Patients with transformed mycosis fungoides are permitted to have received 1
systemic single-agent chemotherapy (other than methotrexate) prior to transformation
of their disease.
4. Prior exposure to pralatrexate.
5. Receipt of systemic corticosteroids within 3 weeks of study treatment, unless patient has
been taking a continuous dose of ≤ 10 mg/day of oral prednisone or equivalent for at least
4 weeks or as part of a CHOP prednisone taper.
6. Planned use of any treatment for PTCL during the course of the study.
7. Patient has:
a. Human immunodeficiency virus (HIV)-positive diagnosis with a CD4 count of
< 100 mm3
or detectable viral load within past 3 months and is receiving
anti-retroviral therapy.
b. HBV-positive serology and is receiving interferon therapy or has liver function test
results outside the parameters of study inclusion criteria. Patients are permitted to
receive other antiviral therapies if the therapy has been administered at a stable dose
for ≥ 4 weeks.
c. Hepatitis C virus (HCV) with detectable viral load or immunological evidence of
chronic active disease or receiving/requiring antiviral therapy.
d. Symptomatic central nervous system (CNS) metastases or lesions for which treatment
is required.
e. Uncontrolled hypertension or congestive heart failure Class III/IV according to the
New York Heart Association’s Heart Failure Guidelines (see
http://www.americanheart.org/presenter.jhtml?identifier=3065080).
f. Active uncontrolled infection, underlying medical condition including unstable
cardiac disease, or other serious illness that would impair the ability of the patient to
receive protocol treatment.
8. Patient has had major surgery within 2 weeks prior to study entry; other than for line
placement or biopsy procedure.
a. Precursor T/NK neoplasms
b. ALCL (ALK+) with IPI score < 2 at initial diagnosis and CR after completion of
CHOP-based therapy
c. T-cell prolymphocytic leukemia (T-PLL)
d. T-cell large granular lymphocytic leukemia
e. Mycosis fungoides, other than transformed mycosis fungoides
f. Sézary syndrome
g. Primary cutaneous CD30+ disorders: ALCL and lymphomatoid papulosis
2. If there is a history of prior malignancies other than those exceptions listed below, the
patient must be disease-free for ≥ 5 years. Patients with the following prior malignancies
less than 5 years before study entry may still be enrolled if they have received treatment
resulting in complete resolution of the cancer and currently have no clinical, radiologic,
or laboratory evidence of active or recurrent disease.
a. Non-melanoma skin cancer
b. Carcinoma in situ of the cervix
c. Localized prostate cancer
d. Localized thyroid cancer
3. Patient has received prior treatment (chemotherapy or radiation) for PTCL, other than a
single allowed CHOP regimen, with the exception of:
a. Patients with nasal NK lymphoma are permitted to have received local radiation
therapy no less than 4 weeks prior to randomization.
b. Patients with transformed mycosis fungoides are permitted to have received 1
systemic single-agent chemotherapy (other than methotrexate) prior to transformation
of their disease.
4. Prior exposure to pralatrexate.
5. Receipt of systemic corticosteroids within 3 weeks of study treatment, unless patient has
been taking a continuous dose of ≤ 10 mg/day of oral prednisone or equivalent for at least
4 weeks or as part of a CHOP prednisone taper.
6. Planned use of any treatment for PTCL during the course of the study.
7. Patient has:
a. Human immunodeficiency virus (HIV)-positive diagnosis with a CD4 count of
< 100 mm3
or detectable viral load within past 3 months and is receiving
anti-retroviral therapy.
b. HBV-positive serology and is receiving interferon therapy or has liver function test
results outside the parameters of study inclusion criteria. Patients are permitted to
receive other antiviral therapies if the therapy has been administered at a stable dose
for ≥ 4 weeks.
c. Hepatitis C virus (HCV) with detectable viral load or immunological evidence of
chronic active disease or receiving/requiring antiviral therapy.
d. Symptomatic central nervous system (CNS) metastases or lesions for which treatment
is required.
e. Uncontrolled hypertension or congestive heart failure Class III/IV according to the
New York Heart Association’s Heart Failure Guidelines (see
http://www.americanheart.org/presenter.jhtml?identifier=3065080).
f. Active uncontrolled infection, underlying medical condition including unstable
cardiac disease, or other serious illness that would impair the ability of the patient to
receive protocol treatment.
8. Patient has had major surgery within 2 weeks prior to study entry; other than for line
placement or biopsy procedure.
The Estimated Number of Participants
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Taiwan
164 participants
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Global
549 participants
