| June 1, 2007 |
| September 29, 2009 |
| May 2007 |
| November 2010 (final data collection date for primary outcome measure) |
| Phase 1: MTD and recommended phase 2 dose, safety and tolerability, and PK profile. Phase 2a: tolerability and preliminary efficacy (based on investigator assessment of response) in relapsed/refractory PTCL and B-Cell Lymphoma. [ Time Frame: Study duration ] [ Designated as safety issue: Yes ] |
| Phase 1: MTD and recommended phase 2 dose, safety and tolerability, and PK profile. Phase 2a: tolerability and preliminary efficacy (based on investigator assessment of response) in relapsed/refractory PTCL. |
| Complete list of historical versions of study NCT00481871 on ClinicalTrials.gov Archive Site |
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| Study of Pralatrexate & Gemcitabine With B12 & Folic Acid to Treat Relapsed/Refractory Lymphoproliferative Malignancies |
| A Phase 1/2a Open-label Study of Sequential Pralatrexate and Gemcitabine With Vitamin B12 and Folic Acid Supplementation in Patients With Relapsed or Refractory Lymphoproliferative Malignancies |
This is a Phase 1/2a, non-randomized, open-label, multi-center study designed to determine the Maximum Tolerated Dose (MTD) of Pralatrexate Injection and Gemcitabine with vitamin B12 and folic acid supplementation to patients with relapsed or refractory lymphoproliferative malignancies. |
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| Phase I, Phase II |
| Interventional |
| Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment |
| Relapsed or Refractory Lymphoproliferative Malignancies |
- Drug: Pralatrexate Injection
- Drug: Gemcitabine hydrochloride (HCl)
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| Experimental: Pralatrexate Injection and Gemcitabine |
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| Recruiting |
| 84 |
| November 2010 |
| November 2010 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Diagnosis per the REAL WHO disease classification.
- Phase 1: Histologically/cytologically confirmed lymphoproliferative malignancy. Patients with Hodgkin's disease or non-Hodgkin's lymphoma are eligible, with the exceptions per exclusion criterion #1.
- Phase 2a: Histologically/cytologically confirmed PTCL or B-cell lymphoma, with the exceptions per exclusion criterion #1.
- Documented disease progression after at least 1 prior treatment, and progression after last prior treatment. Any number of prior therapies is allowed. Patient has recovered from the toxic effects of prior therapy. Patients treated with an FDA-approved monoclonal antibody therapy may be enrolled any time the therapy if they have progression of disease.
- ECOG Performance Status ≤ 2.
- At least 18 years of age.
- Adequate hematological, hepatic, and renal function, including: MMA < 200 nmol/L and Hcy < 10 μmol/L, or receipt of 1 mg oral folic acid daily for at least 10 days prior to planned start of pralatrexate & 1 mg intramuscular vitamin B12 within 10 weeks of the planned start of pralatrexate.
- Women of childbearing potential must agree to practice a medically acceptable contraceptive regimen from study treatment start until at least 30 days after the last administration of pralatrexate and must have a negative serum pregnancy test within 14 days prior to the first day of study treatment.
- Men who are not surgically sterile must agree to practice a medically acceptable contraceptive regimen from study treatment start until at least 90 days after the last administration of pralatrexate.
- Given written informed consent.
Exclusion Criteria:
Phase 1, B-cell:
- Lymphoplasmacytic lymphoma (± Waldenström's macroglobulinemia)
- Plasma cell myeloma/plasmacytoma
- Hairy cell leukemia
Phase 2a, PTCL:
- Precursor T/NK neoplasms, except blastic NK lymphoma
- T-cell prolymphocytic leukemia
- T-cell large granular lymphocytic leukemia
- Mycosis fungoides, except transformed mycosis fungoides
- Sézary syndrome
- Primary cutaneous CD30+ disorders: Anaplastic large cell lymphoma and lymphomatoid papulosis
Phase 2a, B-cell:
- Lymphoplasmacytic lymphoma (± Waldenström's macroglobulinemia)
- Plasma cell myeloma/plasmacytoma
- Hairy cell leukemia
- Relapsed Hodgkin's disease or diffuse large B-cell lymphoma patients who are candidates for high dose therapy and autologous stem cell transplantation and for whom it is a standard curative option.
- Active concurrent malignancy (except non-melanoma skin cancer or carcinoma in situ of the cervix). If there is a history of prior malignancy, must be disease-free for ≥ 5 years.
- NYHA Functional Classification congestive heart failure Class III/IV.
- Uncontrolled hypertension.
- HIV-positive diagnosis and is receiving combination anti-retroviral therapy.
- Central nervous system disease.
- Undergone allogeneic stem cell transplant.
- Relapsed < 100 days from time of an autologous stem cell transplant.
- Patients with disease refractory to peripheral blood stem cell transplant or who have relapsed < 100 days after transplant.
- Active uncontrolled infection or underlying medical condition including unstable cardiac disease, or other serious illness impairing the ability to receive protocol treatment.
- Major surgery within 2 weeks of planned start of treatment.
- Receipt of any conventional chemotherapy or radiation therapy (encompassing > 10% of bone marrow) within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to study treatment or planned use during the study.
- Receipt of systemic corticosteroids within 7 days of study treatment, unless on a continuous dose of ≤ 10 mg/day of prednisone for at least 1 month.
- Use of investigational drugs, biologics, or devices within 4 weeks prior to study treatment or planned use during the study.
- Received a monoclonal antibody within 3 months without evidence of progression.
- Previous exposure to pralatrexate and/or gemcitabine if it was discontinued due to treatment-related toxicity.
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| Both |
| 18 Years and older |
| No |
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| United States |
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| NCT00481871 |
| Medical Monitor, Allos Therapeutics, Inc. |
| PDX-009 |
| Allos Therapeutics |
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| Study Director: |
Michael Saunders, MD |
Allos Therapeutics |
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| Allos Therapeutics |
| September 2009 |