Romidepsin Combination Therapy for Lymphoma

Recruiting in Palo Alto (17 mi)

Overseen byJonathan Brammer, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Ohio State University Comprehensive Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?The goal of this clinical research study is to learn if giving romidepsin before and after a stem cell transplant in combination with fludarabine and busulfan can help to control leukemia or lymphoma. Researchers also want to learn the highest tolerable dose of romidepsin that can be given with this combination. The safety of this combination and the safety of giving romidepsin after a stem cell transplant will also be studied. This is an investigational study. Romidepsin is FDA approved and commercially available for the treatment of CTCL in patients who have received at least 1 systemic (affecting the whole body) therapy before. Busulfan and fludarabine are FDA approved and commercially available for use with a stem cell transplant. The use of the combination of romidepsin, busulfan, and fludarabine to treat the type of leukemia or lymphoma you have is considered investigational. Up to 30 participants will be enrolled in this study. All will take part at MD Anderson.

Eligibility Criteria

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.

Inclusion Criteria

EF >/= 50% on MUGA scan or Echocardiogram

FEV1, FVC and corrected DLCO >/= 40%

Able to sign informed consent

+7 more

Exclusion Criteria

I have not had radiation therapy in the last month.

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

I have been diagnosed with congestive heart failure.

+18 more

Participant Groups

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.

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.

Busulfan is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸 Approved in United States as Busulfex for: