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Alkylating Agent

Romidepsin Combination Therapy for Lymphoma

Phase 1

Waitlist Available

Led By Jonathan Brammer, MD

Research Sponsored by Ohio State University Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of Cutaneous T-Cell Lymphoma, T-Prolymphocytic Leukemia, T-Large Granulocytic Leukemia, T-Lymphoblastic Leukemia/lymphoma, or Peripheral T-Cell Lymphoma, Natural Killer/T-cell lymphoma for whom allogeneic stem cell transplantation is indicated

An 10/10 or 8/8 HLA matched sibling or unrelated donor

Must not have

Myocardial infarction within 1 year of study entry

Congestive heart failure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying a combination of romidepsin, fludarabine, and busulfan to see if it can help control leukemia or lymphoma. Researchers also want to learn the highest tolerable dose of romidepsin that can be given with this combination.

Who is the study for?

This trial is for adults aged 18-70 with certain types of leukemia or lymphoma, such as Cutaneous T-Cell Lymphoma and Peripheral T-Cell Lymphoma, who need a stem cell transplant. Participants must have a matched donor, good heart and lung function, adequate kidney function, normal liver tests, and agree to use birth control.

What is being tested?

The study aims to find the safest high dose of romidepsin when used with fludarabine and busulfan before and after stem cell transplantation in controlling leukemia or lymphoma. All participants will receive this combination at MD Anderson Cancer Center.

What are the potential side effects?

Potential side effects include those common to chemotherapy like nausea, fatigue, low blood counts leading to infection risk; organ toxicity; reactions related to stem cell transplant; plus specific ones from romidepsin which may affect heart rhythm.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with a specific type of T-cell or NK/T-cell lymphoma and need a stem cell transplant.

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I have a donor who is a perfect or near-perfect match for me.

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I am between 18 and 70 years old.

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My kidney function is good, with the right creatinine levels.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had a heart attack in the last year.

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I have been diagnosed with congestive heart failure.

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My high blood pressure is not under control.

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I have a long QT syndrome or my QTc is over 500 ms.

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I have an active brain or spinal cord disease.

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I do not have any ongoing serious infections.

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I have experienced severe side effects from past treatments.

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I have symptoms of heart disease.

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I am HIV positive.

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I have a history of serious heart rhythm problems.

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I have an enlarged or stiff heart muscle.

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I am on medication for an irregular heartbeat.

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I am taking medication that affects my heart's rhythm.

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I am currently taking medication that affects liver enzyme levels.

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I do not have active hepatitis B, cirrhosis, or severe liver fibrosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Efficacy of Romidepsin with Busulfan and Fludarabine Conditioning Therapy for Allogeneic Stem Cell Transplantation

Toxicity of Romidepsin with Busulfan and Fludarabine Conditioning Therapy for Allogeneic Stem Cell Transplantation

Side effects data

From 2010 Phase 2 & 3 trial • 135 Patients • NCT00176904

40%

Death

Auto recovery

Primary graft failure

100%

80%

60%

40%

20%

Study treatment Arm

Patients Treated With Stem Cell Transplant

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Romidepsin + Busulfan + Fludarabine + Stem Cell TransplantExperimental Treatment5 Interventions

Part 1: Busulfan administered at the dose calculated to achieve a total (including first two doses delivered on Day -13 and -12) systemic exposure of 20,000 ± 12% µMol-min based on the pharmacokinetic studies. Fludarabine 40 mg/m2 by vein on Days -6 to -3. Romidepsin dosed per actual body weight/actual body surface area. Romidepsin administered on Day -6, -5, -4, and -3 at escalating doses of 1 mg/m2, 2 mg/m2, and 3 mg/m2 by vein to determine the optimal dose. Participants receiving a graft from a matched unrelated donor receive rabbit Thymoglobulin; 0.5 mg/kg on Day -3, 1.5 mg/kg on Day -2 and 2.0 mg/kg on Day -1. Stem cell infusion on Day 0. Romidepsin Maintenance Therapy - Part 2: Starting between Day +28 and Day +100, if participant is eligible based on disease status, they will continue to receive Romidepsin 8 mg/m2 by vein over 1 hour on Day 1 of each 2-week cycle.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Busulfan

2008

Completed Phase 4

~1710

Romidepsin

2011

Completed Phase 2

~790