430 Participants Needed

Donor Lymphocyte Infusion for Blood Cancers

CG
AH
Overseen ByAmy H Chai
Age: Any Age
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: National Cancer Institute (NCI)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing if giving white blood cells from a donor to patients with high-risk blood cancers can reduce the risk of the cancer coming back. The goal is to see if this approach helps fight off remaining cancer cells and prevents relapse.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot be on any other investigational drugs, and prior experimental treatments must be completed at least 3 weeks before starting the trial.

Is Donor Lymphocyte Infusion and related treatments generally safe for humans?

Research shows that using fludarabine with busulfan in treatments like stem cell transplants tends to have fewer side effects compared to using cyclophosphamide with busulfan. This combination is associated with lower rates of lung injury, liver problems, and certain infections, suggesting it is generally safer.12345

How is the drug combination of Busulfan, Cyclophosphamide, and Fludarabine unique for treating blood cancers?

This drug combination is unique because it uses fludarabine as a less toxic substitute for cyclophosphamide in the standard regimen, potentially reducing side effects while maintaining effectiveness in preparing patients for stem cell transplantation.12367

What data supports the effectiveness of the treatment Donor Lymphocyte Infusion for Blood Cancers?

Research shows that using busulfan and fludarabine together as part of a conditioning regimen before stem cell transplantation is effective for treating acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), with a high complete remission rate and reduced toxicity.12678

Who Is on the Research Team?

CG

Christopher G Kanakry, M.D.

Principal Investigator

National Cancer Institute (NCI)

Are You a Good Fit for This Trial?

Adults aged 18-65 with high-risk blood cancers like leukemia, lymphoma, myelodysplastic syndrome, or multiple myeloma that are hard to treat or likely to come back. They need a healthy relative who can donate bone marrow and white blood cells for the study.

Inclusion Criteria

I have a donor who matches my HLA type.
I can care for myself but may need occasional help.
My related donor is over 12, willing, and able to donate blood, bone marrow, and stool for research.
See 3 more

Exclusion Criteria

I have not undergone intense bone marrow preparation for stem cell transplant.
I do not have any severe illnesses that would make a transplant risky for me.
Recipient must not be actively breastfeeding
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
Multiple visits for various exams and tests

Pre-Transplant Conditioning

Participants receive chemotherapy and other drugs starting 6 days before transplant

1 week
Inpatient stay at NIH hospital

Transplantation

Participants undergo allogeneic hematopoietic cell transplantation

1 day
Inpatient procedure

Donor Lymphocyte Infusion (DLI)

Participants receive donor lymphocyte infusion 7 days post-transplant

1 day
Inpatient procedure

Post-Transplant Monitoring

Participants are monitored for development of GVHD and other outcomes

100 days
Frequent follow-up visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years
Periodic follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

  • Busulfan
  • Cyclophosphamide
  • Donor Lymphocyte Infusion
  • Fludarabine
  • Mycophenolate mofetil
  • Sirolimus
Trial Overview The trial is testing if giving patients donor lymphocytes (white blood cells) from their transplant donor soon after a bone marrow transplant can lower the chance of cancer coming back. It includes chemotherapy drugs and staying near NIH for monitoring.
How Is the Trial Designed?
5Treatment groups
Experimental Treatment
Active Control
Group I: Phase II Efficacy, Cohort 2 (haploidentical)Experimental Treatment6 Interventions
Group II: Phase II Efficacy, Cohort 1 (matched)Experimental Treatment6 Interventions
Group III: Phase I Dose Escalation, Cohort 2 (haploidentical)Experimental Treatment6 Interventions
Group IV: Phase I Dose Escalation, Cohort 1 (matched)Experimental Treatment6 Interventions
Group V: Donor ArmActive Control1 Intervention

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

๐Ÿ‡บ๐Ÿ‡ธ
Approved in United States as Busulfex for:
๐Ÿ‡ช๐Ÿ‡บ
Approved in European Union as Busulfan for:
๐Ÿ‡จ๐Ÿ‡ฆ
Approved in Canada as Busulfex for:
๐Ÿ‡ฏ๐Ÿ‡ต
Approved in Japan as Busulfan for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

A population pharmacokinetic/pharmacodynamic model was developed using data from 41 hematopoietic cell transplant recipients to understand how different concentrations of F-ara-A affect lymphocyte suppression.
The model successfully characterized the variability in absolute lymphocyte counts during treatment, indicating that the specific HCT protocol significantly influenced lymphocyte kill rates and could help optimize future fludarabine-based conditioning regimens.
Population pharmacokinetic/dynamic model of lymphosuppression after fludarabine administration.McCune, JS., Vicini, P., Salinger, DH., et al.[2021]
In a study involving 16 patients with hematological malignancies, the pharmacokinetics of fludarabine were assessed before and after administration of busulfan, showing no significant changes in key parameters such as clearance and half-life.
The results suggest that there is unlikely to be a clinically relevant drug interaction between busulfan and fludarabine, supporting their combined use in conditioning regimens for stem cell transplantation.
F-ara-A pharmacokinetics during reduced-intensity conditioning therapy with fludarabine and busulfan.Bonin, M., Pursche, S., Bergeman, T., et al.[2013]
The combination of intravenous busulfan and fludarabine as a conditioning therapy for allogeneic hematopoietic stem cell transplantation (HSCT) in patients with acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS) demonstrated a high complete remission rate of 85% in patients with active disease.
This regimen showed low regimen-related (1%) and treatment-related (3%) mortality rates, indicating improved safety, while achieving a 1-year overall survival rate of 65% and event-free survival rate of 52% for all patients, suggesting it is an effective and reduced-toxicity option for these conditions.
Once-daily intravenous busulfan and fludarabine: clinical and pharmacokinetic results of a myeloablative, reduced-toxicity conditioning regimen for allogeneic stem cell transplantation in AML and MDS.de Lima, M., Couriel, D., Thall, PF., et al.[2021]

Citations

Population pharmacokinetic/dynamic model of lymphosuppression after fludarabine administration. [2021]
F-ara-A pharmacokinetics during reduced-intensity conditioning therapy with fludarabine and busulfan. [2013]
Once-daily intravenous busulfan and fludarabine: clinical and pharmacokinetic results of a myeloablative, reduced-toxicity conditioning regimen for allogeneic stem cell transplantation in AML and MDS. [2021]
[A comparison of toxicity and efficacy between busulfan plus fludarabine and busulfan plus cyclophosphamide for allogeneic hematopoietic stem cell transplantation in acute myeloid leukemia]. [2014]
New myeloablative conditioning regimen with fludarabine and busulfan for allogeneic stem cell transplantation: comparison with BuCy2. [2022]
Fludarabine-based myeloablative regimen as pretransplant conditioning therapy in adult acute leukemia/myelodysplastic syndrome: comparison with oral or intravenous busulfan with cyclophosphamide. [2021]
Fludarabine and exposure-targeted busulfan compares favorably with busulfan/cyclophosphamide-based regimens in pediatric hematopoietic cell transplantation: maintaining efficacy with less toxicity. [2014]
Influence of fludarabine on the pharmacokinetics of oral busulfan during pretransplant conditioning for hematopoietic stem cell transplantation. [2013]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of ServiceยทPrivacy PolicyยทCookiesยทSecurity