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Study Summary
No. 2008-0225:.......Lymphoma......Barbara Pro......Lymphoma/Myeloma
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Study Summary Title
Study Summary
Number:		2008-0225
Study Title:A Phase I/IIa Open-label Study of Pralatrexate and Gemcitabine with Vitamin B12 and Folic Acid Supplementation in Patients with Relapsed or Refractory Lymphoproliferative Malignancies
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Physician New Patient Referral
Name:Barbara ProPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Lymphoma/MyelomaReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-2830
Contact us about clinical trials
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General Information
Disease Group:LymphomaSupported By:Allos Therapeutics, Inc
Phase of Study:Phase I/Phase IIReturn
Visit:		Pts receive cycles of pralatrexate-gemcitabine txt w/ concurrent vitamin
supplementation. One cycle of txt will be 4 wks in duration consisting of wkly
or bi-wkly dosing depending on txt group. App 30-40 days after last dose, final
follow-up visit.
Treatment
Agents:		Folic Acid
Gemcitabine
Pralatrexate
Vitamin B12		Home Care:NA
Treatment Loc:Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions
Estimated
Length of Stay
in Houston:		NA
Description/
Intervention:		The goal of this clinical research study is to learn if the combination of
pralatrexate and Gemzar® (gemcitabine) is tolerable and can help to control the
disease when given to patients with B-cell lymphoma, peripheral T-cell lymphoma
or Hodgkin's lymphoma with Vitamin B12 and folic acid supplementation.
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Study Objectives / Outcomes
1) To determine the maximum tolerated dose (MTD) and recommended Phase 2 dose of intravenous (IV) pralatrexate and gemcitabine that can be administered with vitamin B12 and folic acid supplementation in patients with relapsed or refractory lymphoproliferative malignancies (Phase 1).

2) To evaluate the safety and tolerability of escalating doses of pralatrexate and gemcitabine when administered with vitamin B12 and folic acid supplementation in this patient population (Phase 1).

3) To determine the pharmacokinetic (PK) profile of pralatrexate and gemcitabine when administered with vitamin B12 and folic acid supplementation in this patient population (Phase 1 and 2).

4) To confirm tolerability and assess preliminary efficacy in patients with relapsed or refractory Hodgkins Lymphoma (HL), peripheral T-Cell lymphoma (PTCL), and B-cell lymphoma (Phase 2).
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Study Status Information
Study Activation / Registration Date:02/09/2009
IRB Review and Approval Date:06/30/2008
Study Type:Phase Ii Or Phase I/Ii
Recruitment Status:Open
Projected Accrual:42
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
Inclusion Criteria:1) Diagnosis will be per the Revised European American Lymphoma (REAL) World Health Organization (WHO) disease classification. Phase 1: Histologically or cytologically confirmed lymphoproliferative malignancy. Patients with either HL or non-Hodgkin's lymphoma are eligible, with the exception of patients with particular B-cell lymphomas, as per exclusion criterion #1. Phase 2a: Histologically/cytologically confirmed HL, PTCL or B-cell lymphoma including Waldenström's macroglobulinemia (with the exceptions per exclusion criterion #1).

2) Documented progression of disease after at least 1 prior treatment. Any number of prior therapies will be allowed. The patient should have clearly progressed after their last prior treatment regimen. The patient has recovered from the toxic effects of prior therapy. Patients treated with a Food and Drug Administration (FDA)-approved monoclonal antibody therapy may be enrolled regardless of the time frame after the therapy if they have progression of disease.

3) Eastern Cooperative Oncology Group (ECOG) Performance Status </= 2.

4) At least 18 years of age.

5) Adequate hematological, hepatic, and renal function as defined by: absolute neutrophil count (ANC) >/= 1000/microL, platelet count >/= 100,000/microL, total bilirubin </= 1.5 mg/dL, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) </= 2.5 × upper limit of normal (ULN) (AST/ALT </= 5 × ULN if documented hepatic involvement with lymphoma), creatinine </=1.5 mg/dL or calculated creatinine clearance >/= 50 mL/min.

6) The patient has been on a regimen of 1 mg PO QD of folic acid for at least 7 days prior to planned start of pralatrexate and has received 1 mg IM of vitamin B12 within 10 weeks of the planned start of pralatrexate.

7) Females of childbearing potential must agree to practice a medically acceptable contraceptive regimen from study treatment initiation 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. Patients who are postmenopausal for at least 1 year (defined as > 12 months since last menses) or are surgically sterilized do not require this test.

8) Males who are not surgically sterile must agree to practice a medically acceptable contraceptive regimen from study treatment initiation until at least 90 days after the last administration of pralatrexate.

9) Given written informed consent (IC).
Exclusion Criteria:1) Phase 1 B-cell: a. Lymphoplasmacytic lymphoma (± Waldenström's macroglobulinemia) b. Plasma cell myeloma/plasmacytoma; c. Hairy cell leukemia; Phase 2a PTCL: a. Precursor T/NK neoplasms, with the exception of blastic NK lymphoma b. T-cell prolymphocytic leukemia (T-PLL) c. T-cell large granular lymphocytic leukemia d. Mycosis fungoides, other than transformed mycosis fungoides e. Sézary syndrome f. Primary cutaneous CD30+ disorders: Anaplastic large cell lymphoma and lymphomatoid papulosis; B-cell: a. Plasma cell myeloma/plasmacytoma; b. Hairy cell leukemia

2) Continuation Exclusion#1) Phase 2a B-cell: a.Plasma cell myeloma/plasmacytoma; b. Hairy cell leukemia

3) Relapsed Hodgkin's disease or diffuse large B-cell lymphoma who are candidates for high dose therapy and autologous stem cell transplantation and for whom high dose therapy and autologous stem cell transplantation is a standard curative option.

4) Active concurrent malignancy (except non-melanoma skin cancer or carcinoma in situ of the cervix). If there is a history of prior malignancy, the patient must be disease-free for >/=5 years.

5) Congestive heart failure Class III/IV according to the New York Heart Association (NYHA) Functional Classification.

6) Patients with uncontrolled hypertension (i.e. > 190/110)

7) Human immunodeficiency virus (HIV)- positive diagnosis with CD4 < 100 or detectable viral load within past 3 months and receiving anti-retroviral therapy.

8) Hepatitis B virus (HBV) diagnosis or hepatitis C virus (HCV) diagnosis with detectable viral load or immunological evidence of chronic active disease or receiving/requiring antiviral therapy.

9) Central nervous system (CNS) disease.

10) Undergone an allogeneic stem cell transplant.

11) Patients with disease refractory to peripheral blood stem cell transplant (PBSCT) or who have relapsed < 100 days from the time of transplant are not eligible.

12) 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.

13) Major surgery within 2 weeks of planned start of treatment.

14) Receipt of any conventional chemotherapy or radiation therapy (RT) (encompassing a substantial [> 10%] amount of bone marrow) within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to study treatment or planned use during the course of the study.

15) Receipt of systemic corticosteroids within 7 days of study treatment, unless patient has been taking a continuous dose of no more than 10 mg/day of prednisone for at least 1 month.

16) Use of any investigational drugs, biologics, or devices within 4 weeks prior to study treatment or planned use during the course of the study.

17) Received a monoclonal antibody within 3 months without evidence of progression.

18) Previous exposure to pralatrexate if it was discontinued due to treatment-related toxicity.

19) Previous exposure to gemcitabine if it was discontinued due to treatment-related toxicity.
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Links
Registration Number: NCT00481871
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
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Results

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