Romidepsin, Ifosfamide, Carboplatin, and Etoposide in Treating Participants With Relapsed or Refractory Peripheral T-Cell Lymphoma
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|ClinicalTrials.gov Identifier: NCT01590732|
Recruitment Status : Completed
First Posted : May 3, 2012
Last Update Posted : September 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Mycosis Fungoides Recurrent Anaplastic Large Cell Lymphoma Recurrent Angioimmunoblastic T-Cell Lymphoma Recurrent Enteropathy-Associated T-Cell Lymphoma Recurrent Hepatosplenic T-Cell Lymphoma Recurrent Peripheral T-Cell Lymphoma, Not Otherwise Specified Refractory Anaplastic Large Cell Lymphoma Refractory Angioimmunoblastic T-Cell Lymphoma Refractory Enteropathy-Associated T-Cell Lymphoma Refractory Hepatosplenic T-Cell Lymphoma Refractory Peripheral T-Cell Lymphoma, Not Otherwise Specified||Drug: Carboplatin Drug: Etoposide Drug: Ifosfamide Drug: Romidepsin||Phase 1|
I. To assess the safety profile of romidepsin given before and after ifosfamide, carboplatin, etoposide (ICE) chemotherapy for patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).
II. To determine the maximum tolerated dose (MTD), if reached, of romidepsin administered in combination with ICE chemotherapy in patients with relapsed or refractory PTCL.
I. To determine the overall response rate (ORR) and complete response (CR) rate in patients with relapsed or refractory PTCL.
OUTLINE: This is a dose-escalation study of romidepsin.
Participants receive romidepsin intravenously (IV) over 4 hours on days 1 and 4, ifosfamide IV over 24 hours on day 1, carboplatin IV over 1 hour on day 1, and etoposide IV over 2 hours on day 1-3. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, participants are followed up within 2-4 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of Romidepsin (ISTODAX®) Plus ICE for Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma|
|Actual Study Start Date :||October 29, 2012|
|Actual Primary Completion Date :||May 2, 2018|
|Actual Study Completion Date :||May 2, 2018|
Experimental: Treatment (romidepsin, ifosfamide, carboplatin, etoposide)
Participants receive romidepsin IV over 4 hours on days 1 and 4, ifosfamide IV over 24 hours on day 1, carboplatin IV over 1 hour on day 1, and etoposide IV over 2 hours on day 1-3. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
- Maximum tolerated dose [ Time Frame: Up to 4 weeks post treatment ]
- Incidence of adverse events [ Time Frame: Up to 4 weeks post treatment ]
- Overall response rate [ Time Frame: Up to 5.5 years ]Point estimates along with 95% confidence intervals will be provided.
- Complete response [ Time Frame: Up to 5.5 years ]Point estimates along with 95% confidence intervals will be provided.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01590732
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Michelle Fanale||M.D. Anderson Cancer Center|