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Alkylating agents

Chemotherapy + Stem Cell Transplant for Lymphoma

Phase 1 & 2

Waitlist Available

Led By Yago L Nieto, MD,PHD

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

Men and women of reproductive potential must agree to follow accepted birth control methods for the duration of the study; female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study; male subject agrees to use an acceptable method for contraception for the duration of the study

Patients with refractory B-cell or T-cell non-Hodgkin's lymphoma or Hodgkin's lymphoma who are eligible for allogeneic transplantation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is testing a new chemotherapy combination before a stem cell transplant to treat patients with B-cell or T-cell non-Hodgkin lymphoma or Hodgkin lymphoma that has not responded to treatment.

Who is the study for?

This trial is for patients with B-cell or T-cell non-Hodgkin lymphoma or Hodgkin lymphoma that's resistant to treatment. Participants must have a matched donor for stem cell transplant, good heart and lung function, normal liver and kidney tests, and agree to birth control methods. Excluded are those with HIV, uncontrolled infections, severe recent toxicity from treatments, certain prior radiation therapies or transplants, active brain disease, pregnancy/breastfeeding women, and active hepatitis.Check my eligibility

What is being tested?

The study is testing the effectiveness of chemotherapy drugs gemcitabine hydrochloride, clofarabine, busulfan before a donor stem cell transplant in treating stubborn lymphomas. It aims to find the best dose while assessing how well it prepares patients' bodies for accepting donor stem cells which can help rebuild healthy blood cells.See study design

What are the potential side effects?

Potential side effects include reactions to chemotherapy such as nausea/vomiting; damage to organs like the heart/liver/kidneys; increased risk of infection due to immune system suppression; mouth sores; fatigue; hair loss. The transplant process may also cause graft-versus-host disease where donated cells attack the patient's body.

Eligibility Criteria

Inclusion Criteria

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

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I agree to use effective birth control during the study.

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I have a type of lymphoma that hasn't responded to treatment and am eligible for a stem cell transplant from a donor.

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My kidneys are working well, with a creatinine clearance of at least 50 ml/min.

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I have a donor who is a perfect match for my transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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

Complete response rate (Phase II)

Incidence of grade 2-4 and grade 3-4 acute GVHD (Phase II)

Incidence of limited and extensive chronic GVHD (Phase II)

+5 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (gemcitabine, clofarabine, busulfan, BMT or PBSCT)Experimental Treatment11 Interventions

PREPARATIVE REGIMEN: Patients receive gemcitabine hydrochloride IV over 40-180 minutes on days -6 and -4, clofarabine IV over 1 hour on days -6 to -3, and busulfan IV over 3 hours on days -6 to -3. Patients with matched unrelated donors also receive antithymocyte globulin IV on days -3 to -1 and patients with CD20-positive disease also receive rituximab IV on days -14, -7, 1, and 8. TRANSPLANT: Patients undergo allogeneic BMT or PBSCT on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously over 24 hours or PO beginning on day -2 for up to 6 months and mycophenolate mofetil IV over 2 hours or PO TID beginning day 0.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Clofarabine

2007

Completed Phase 3

~1130

Busulfan

2008

Completed Phase 3

~1120

Tacrolimus

2011

Completed Phase 4

~4740

Gemcitabine Hydrochloride

2005

Completed Phase 3

~5420

Allogeneic Hematopoietic Stem Cell Transplantation

2012

Completed Phase 2

~1200

Peripheral Blood Stem Cell Transplantation

1997

Completed Phase 3

~1330

Rituximab

1999

Completed Phase 4

~1880

Anti-Thymocyte Globulin

2009

Completed Phase 4

~980

Mycophenolate Mofetil

1997

Completed Phase 4

~2380

Allogeneic Bone Marrow Transplantation

2009

Completed Phase 2

~470

0 / 4Eligibility criteria met

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,976 Previous Clinical Trials

1,789,428 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,687 Previous Clinical Trials

40,930,291 Total Patients Enrolled

Yago L Nieto, MD,PHDPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Busulfan (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT01701986 — Phase 1 & 2

Hodgkin's Lymphoma Research Study Groups: Treatment (gemcitabine, clofarabine, busulfan, BMT or PBSCT)

Hodgkin's Lymphoma Clinical Trial 2023: Busulfan Highlights & Side Effects. Trial Name: NCT01701986 — Phase 1 & 2

Busulfan (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01701986 — Phase 1 & 2

Frequently Asked Questions

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

Is it currently feasible to participate in this investigation?

"Per clinicaltrials.gov, this research project has stopped recruiting patients. It was made public on October 25th 2012 and the listing was amended lastly on August 18th 2022. Notwithstanding, there are 2887 additional studies currently ready to enrol participants."

Answered by AI

What afflictions is Allogeneic Bone Marrow Transplantation usually employed to address?

"Allogeneic Bone Marrow Transplantation is often used to treat urinary bladder but can be beneficial for other diseases like small cell lung cancer (sclc), dermatitis, atopic and refractory langerhans cell histiocytosis."

Answered by AI

Who would be ideal candidates to participate in this experiment?

"This clinical trial is accepting patients with Hodgkin Disease between the ages of 12 and 65. Currently, there are 80 spots open for enrolment."

Answered by AI

Are there any historical precedents of Allogeneic Bone Marrow Transplantation trials?

"Currently, 1101 Allogeneic Bone Marrow Transplantation trials are ongoing with 261 in the late-stage Phase 3. Philadelphia, Pennsylvania is a hotbed for this type of research; however there exists over 41011 sites conducting Allogeneic Bone Marrow Transplantation studies."

Answered by AI

How many participants are the maximum allowed to participate in this experiment?

"At this moment in time, no patients are being recruited for the trial initially posted on October 25th 2012 and last edited August 18th 2022. For those looking to be involved with other clinical trials, there is a total of 1786 studies recruiting participants suffering from Hodgkin's Disease and 1101 medical investigations seeking individuals suitable for Allogeneic Bone Marrow Transplantation."

Answered by AI

Are individuals of 20 or more years old entitled to participate in this scientific experiment?

"In order to qualify for this investigation, applicants must be within the age bracket of 12 and 65 years old. Separately, there are 526 studies specifically targeting participants under 18, as well as 2598 trials that offer enrolment opportunities to individuals over 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Gemcitabine Hydrochloride, Clofarabine, and Busulfan Before Donor Stem Cell Transplant in Treating Patients With Refractory B-Cell or T-Cell Non-Hodgkin Lymphoma or Hodgkin Lymphoma

2012. "Gemcitabine Hydrochloride, Clofarabine, and Busulfan Before Donor Stem Cell Transplant in Treating Patients With Refractory B-Cell or T-Cell Non-Hodgkin Lymphoma or Hodgkin Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01701986.

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