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Alkylating Agent

Vorinostat + Chemotherapy Before Stem Cell Transplant for Non-Hodgkin's Lymphoma

Phase 2
Waitlist Available
Led By Yago L Nieto
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights

Study Summary

This trial is studying vorinostat in combination with chemotherapy before a stem cell transplant to see how well it works compared to chemotherapy alone in treating patients with relapsed aggressive B-cell or T-cell non-Hodgkin lymphoma.

Who is the study for?
This trial is for adults with aggressive B-cell or T-cell non-Hodgkin lymphoma that has relapsed. Participants need a matched donor for stem cell transplantation, good heart and lung function, normal liver tests, and must use birth control. It's not open to those with severe liver damage, HIV, uncontrolled infections, recent brain irradiation or stem cell transplant, active CNS disease, pregnancy/breastfeeding women, hepatitis B carriers or those on other investigational drugs.Check my eligibility
What is being tested?
The study is testing the effectiveness of vorinostat combined with chemotherapy (busulfan, gemcitabine & clofarabine) before undergoing donor stem cell transplantation in controlling relapsed lymphoma. Vorinostat targets cancer growth enzymes while the chemo drugs work to kill or stop cancer cells from growing.See study design
What are the potential side effects?
Potential side effects include reactions related to vorinostat such as stomach issues and fatigue; chemotherapy can cause nausea/vomiting, hair loss and increased risk of infection; stem cell transplantation may lead to graft-versus-host disease where donated cells attack your body.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free survival
Secondary outcome measures
Complete response rate
Early treatment success
Objective response rate
+1 more

Side effects data

From 2019 Phase 2 trial • 77 Patients • NCT01251575
5%
Hypoxia
5%
Febrile neutropenia
5%
Acute kidney injury
4%
Blood bilirubin increased
4%
Diarrhea
4%
Creatinine increased
4%
Sepsis
3%
Hypotension
3%
Left ventricular systolic dysfunction
3%
Bronchopulmonary hemorrhage
3%
Chronic kidney disease
3%
Thromboembolic event
3%
Lung infection
1%
Atrial fibrillation
1%
Atrial flutter
1%
Hemolysis
1%
Hemolytic uremic syndrome
1%
Ejection fraction decreased
1%
Encephalitis infection
1%
Gastric hemorrhage
1%
Gastritis
1%
Heart failure
1%
Mucositis oral
1%
Multi-organ failure
1%
Myalgia
1%
Pleural effusion
1%
Respiratory failure
1%
Small intestine infection
1%
Syncope
1%
Treatment related secondary malignancy
1%
Typhlitis
1%
Fever
1%
Paroxysmal atrial tachycardia
1%
Ascites
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Fludarabine, Transplant, Immunosuppression)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (busulfan, vorinostat, gemcitabine, clofarabine)Experimental Treatment9 Interventions
Patients receive a low-level "test" dose of busulfan IV over up to 1 hour on days -15 to -9, vorinostat PO QD on days -8 to -4, gemcitabine IV over about 90 minutes on days -7 and -5, clofarabine IV over about 1 hour and high-dose busulfan IV over 3 hours on days -7 to -4. Patients with CD20 positive (+) lymphoma also receive rituximab IV over 3 to 6 hours on days -15, -8, 1, and 8. Patients undergo HSCT on day 0. Patients then receive cyclophosphamide IV over 2 hours on days 3 and 4. Beginning day 5, patients receive standard of care tacrolimus IV over 24 hours and mycophenolate mofetil IV over 2 hours TID until they can be tolerated PO. Once tolerated PO, patients receive tacrolimus PO BID for 6 months and mycophenolate mofetil PO TID for up to 30 days in the absence of disease progression or unacceptable toxicity. After 30 days, patients who develop GVHD continue treatment with mycophenolate mofetil at physician's discretion
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3770
Rituximab
1999
Completed Phase 4
~1880
Tacrolimus
2011
Completed Phase 4
~4740
Vorinostat
2014
Completed Phase 3
~1600
Allogeneic Hematopoietic Stem Cell Transplantation
2012
Completed Phase 2
~1200
Mycophenolate Mofetil
1997
Completed Phase 4
~2380
Clofarabine
2007
Completed Phase 3
~1130
Gemcitabine
2017
Completed Phase 3
~2070
Busulfan
2008
Completed Phase 3
~1120

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,667 Total Patients Enrolled
138 Trials studying Burkitt Lymphoma
14,634 Patients Enrolled for Burkitt Lymphoma
M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,802 Total Patients Enrolled
7 Trials studying Burkitt Lymphoma
527 Patients Enrolled for Burkitt Lymphoma
Yago L NietoPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
185 Total Patients Enrolled

Media Library

Busulfan (Alkylating Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04220008 — Phase 2
Burkitt Lymphoma Research Study Groups: Treatment (busulfan, vorinostat, gemcitabine, clofarabine)
Burkitt Lymphoma Clinical Trial 2023: Busulfan Highlights & Side Effects. Trial Name: NCT04220008 — Phase 2
Busulfan (Alkylating Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04220008 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What risks are associated with Allogeneic Hematopoietic Stem Cell Transplantation?

"There is some evidence of the security of Allogeneic Hematopoietic Stem Cell Transplantation, so it earned a rating of 2. As this phase two trial has not yet revealed results on efficacy, more research needs to be done before drawing any conclusions."

Answered by AI

What is the size of the population being treated in this experimental research?

"At this moment, the research team is not enrolling additional participants. The trial was first advertised on June 1st 2023 and its information was most recently updated on June 29th 2022. Those looking to join other studies may find success with 2745 trials actively seeking patients who suffer from lymphoma, large b-cell diffuse or 1692 Allogeneic Hematopoietic Stem Cell Transplantation investigations that are accepting recruits."

Answered by AI

What empirical evidence has been gathered regarding Allogeneic Hematopoietic Stem Cell Transplantation?

"As of the present moment, 1,692 clinical trials are running to investigate Allogeneic Hematopoietic Stem Cell Transplantation; 364 of these experiments have reached Phase 3. Notably, most studies related to this procedure take place in St Leonards, New South Wales but there are 62,035 sites conducting testing worldwide."

Answered by AI

Are persons beyond thirty years of age eligible to enter this experiment?

"This clinical trial welcomes individuals aged 12 and over, but younger than 65 years old."

Answered by AI

What are the primary health ailments that Allogeneic Hematopoietic Stem Cell Transplantation is used to address?

"Allogeneic Hematopoietic Stem Cell Transplantation is a viable treatment for urinary bladder, refractory langerhans cell histiocytosis and lung cancers."

Answered by AI

Would I meet the eligibility criteria to join this experiment?

"This medical experiment is accepting applications from individuals aged 12 to 65 with relapsed aggressive B-cell Non Hodgkin lymphoma, transformed non-Hodgkin's Lymphoma, high risk grade B-Cell lymphoma or Burkitt. Notably applicants must have received a minimum of one line of chemotherapy without improvement and a very high disease risk index (DRI). All in all, 30 patients are required for this trial."

Answered by AI

Are participants still being enrolled for this clinical experiment?

"At the present moment, no patients are being sought for this clinical trial. The study was first published on June 1st 2023 and most recently updated on June 29th 2022. As an alternative option, there exist 2,745 trials searching for lymphoma patients with large b-cell diffuse and another 1,692 studies actively recruiting participants for Allogeneic Hematopoietic Stem Cell Transplantation."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Vorinostat and Combination Chemotherapy Before Donor Stem Cell Transplantation for the Treatment of Relapsed Aggressive B-cell or T-cell Non-Hodgkin Lymphoma
2021. "Vorinostat and Combination Chemotherapy Before Donor Stem Cell Transplantation for the Treatment of Relapsed Aggressive B-cell or T-cell Non-Hodgkin Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04220008.
~0 spots leftby Apr 2025
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