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506U78 in Treating Patients With Lymphoma | Clinical Trials | Clareo Health

COMPLETEDPHASE2

506U78 in Treating Patients With Lymphoma

A Phase II Study of 506U78 in Patients With Previously Systemically Untreated Cutaneous T-cell Lymphoma (CTCL) or With Refractory or Relapsed Non-cutaneous Peripheral T-cell Lymphoma (PTCL)

NCT00005080•National Cancer Institute (NCI)

View on ClinicalTrials.gov

Summary

Phase II trial to study the effectiveness of 506U78 in treating patients who have lymphoma that has not been treated previously or that has not responded to previous treatment. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die

Detailed Description

PRIMARY OBJECTIVES: I. Determine the complete and partial remission rates and remission duration in patients with cutaneous T-cell lymphoma or refractory or relapsed noncutaneous peripheral T-cell lymphoma treated with 506U78. II. Determine the safety and toxicity of this treatment regimen in this patient population. OUTLINE: Patients receive 506U78 IV over 2 hours on days 1, 3, and 5. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete response receive up to 8 courses of therapy. Patients are followed every 3 months for 1 year and then every 6 months for 1 year or until relapse. PROJECTED ACCRUAL: A total of 34-74 patients will be accrued for this study within 3 years.

Eligibility

Age

0 - 69 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically documented cutaneous T-cell lymphoma (CTCL) or noncutaneous peripheral T-cell lymphoma (PTCL) (needle aspirate or core biopsy of tissue or marrow as the sole means of diagnosis is not acceptable), confirmed by immunophenotyping, including:
•* Mycosis fungoides/Sezary syndrome
•* Peripheral T-Cell lymphomas (medium, mixed medium-large, large cell)
•* Variants of peripheral T-Cell lymphoma
•* Angioimmunoblastic T-Cell lymphoma (AILD); angiocentric lymphoma; intestinal T-Cell Lymphoma; adult T-Cell lymphoma/leukemia (ATLL); anaplastic Large Cell (CD30+) lymphoma, T-cell type Failure to submit pathology slides within 60 days of patient registration will result in patient being declared ineligible; Note: patients diagnosed more than one year prior to entry on this protocol must have a repeat lymph node biopsy. In the event of rapid tumor growth, rising LDH, or the onset of B symptoms in a period of time less than one year a rebiopsy is also required
•Biopsy and immunophenotyping should be performed to document relapse after prior treatment
•CTCL patients may have received one prior course of single-agent systemic chemotherapy for CTCL, but may not have received a multi-agent chemotherapy regimen; patients may have received prior local, topical, radiation- or electron beam-based, or chemotherapy-based treatment; examples of the latter would include, but not be limited to, cytokines such as interferon, retinoids, monoclonal antibodies, and fusion toxins
•PTCL patients may have failed only one or two prior treatment regimens (one of which may include peripheral stem cell transplantation)
•Patients must have measurable disease; patients with CTCL must have skin lesions which are measurable; whenever CT is specified, it should be understood that MRI may be substituted as long as the measurements for tumor response are made on two successive studies employing the same procedure
•* The following lesions are not considered measurable:
+7 more criteria

Exclusion Criteria

•Calculated Creatinine Clearance \>= 50 ml/min
•* Unless attributable to lymphoma
•* To be calculated by method of Cockcroft-Gault
•Bilirubin \>= 1.5 x upper limit of normal
•* Patients with hepatic dysfunction should enroll on CALGB 69803

Locations (1)

Cancer and Leukemia Group B

Chicago, Illinois, United States

Key Dates

Start Date

May 1, 2000

Primary Completion Date

January 1, 2006

Last Updated

January 16, 2013

Enrollment

ACTUAL participants

Conditions

Anaplastic Large Cell LymphomaAngioimmunoblastic T-cell LymphomaRecurrent Adult T-cell Leukemia/LymphomaRecurrent Cutaneous T-cell Non-Hodgkin LymphomaRecurrent Mycosis Fungoides/Sezary SyndromeSmall Intestine LymphomaStage I Cutaneous T-cell Non-Hodgkin LymphomaStage I Mycosis Fungoides/Sezary SyndromeStage II Cutaneous T-cell Non-Hodgkin LymphomaStage II Mycosis Fungoides/Sezary SyndromeStage III Cutaneous T-cell Non-Hodgkin LymphomaStage III Mycosis Fungoides/Sezary SyndromeStage IV Cutaneous T-cell Non-Hodgkin LymphomaStage IV Mycosis Fungoides/Sezary Syndrome

Interventions

nelarabine

DRUG

Azacitidine and Abatacept in Relapsed or Refractory T-Cell Lymphoma

NCT07388563

Lymphoma, T Cell, PeripheralT-cell Lymphoma+4 more

View study

RECRUITINGPHASE3

Soquelitinib vs Standard of Care in Participants With Relapsed/Refractory Peripheral T-cell Lymphoma Not Otherwise Specified, Follicular Helper T-cell Lymphomas, or Systemic Anaplastic Large-cell Lymphoma

NCT06561048

Peripheral T-Cell Lymphoma, Not Otherwise SpecifiedAngioimmunoblastic T-cell Lymphoma+5 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 16, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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506U78 in Treating Patients With Lymphoma

Inclusion Criteria

Exclusion Criteria

Azacitidine and Abatacept in Relapsed or Refractory T-Cell Lymphoma

Soquelitinib vs Standard of Care in Participants With Relapsed/Refractory Peripheral T-cell Lymphoma Not Otherwise Specified, Follicular Helper T-cell Lymphomas, or Systemic Anaplastic Large-cell Lymphoma

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