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Allogeneic Hematopoietic Stem Cell Transplantation for Mantle Cell Lymphoma

Fred Hutch/University of Washington Cancer Consortium, Seattle, WA
Mantle Cell Lymphoma+19 More ConditionsAllogeneic Hematopoietic Stem Cell Transplantation - Procedure
Eligibility
Any Age
All Sexes

Study Summary

This trial is testing a donor stem cell transplant with chemotherapy and radiation to see if it can treat blood cancers.

Eligible Conditions
  • Mantle Cell Lymphoma
  • Diffuse Large B-Cell Lymphoma
  • Prolymphocytic Leukaemia
  • Large Cell Anaplastic Lymphoma
  • Lymphoblastic Lymphoma
  • Lymphoplasmacytic Lymphoma
  • Refractory Follicular Lymphoma
  • Acute Leukemia
  • Refractory Marginal Zone Lymphoma
  • Small Lymphocytic Lymphoma (SLL)
  • Burkitt Lymphoma
  • Chronic Myelogenous Leukemia (CML)
  • Chronic Lymphocytic Leukemia (CLL)
  • Chronic Myeloid Leukemia (CML)
  • Chronic Myelomonocytic Leukemia
  • Hodgkin's Lymphoma
  • Mixed Phenotype Acute Leukemia
  • Acute Myeloid Leukemia
  • Myelodysplastic Syndrome
  • Acute Lymphoblastic Leukemia

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

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Study Objectives

1 Primary · 8 Secondary · Reporting Duration: At 1- and 2-years post-transplant

At 1 year post-transplant
Progression free survival
At 1- and 2-years post-transplant
Overall survival
At 1- and 2-years post-treatment
Cumulative incidence of relapse
Year 1
Non-relapse mortality
At day 100 post-transplant
Platelet engraftment
Year 2
Acute graft versus host disease
Chronic graft versus host disease
Clinically significant infections
Graft failure/rejection

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

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Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2 Treatment Groups

Arm A (high dose treosulfan)
1 of 2
Arm B (low dose treosulfan)
1 of 2

Experimental Treatment

60 Total Participants · 2 Treatment Groups

Primary Treatment: Allogeneic Hematopoietic Stem Cell Transplantation · No Placebo Group · Phase 2

Arm A (high dose treosulfan)Experimental Group · 9 Interventions: Allogeneic Hematopoietic Stem Cell Transplantation, Filgrastim, Cyclophosphamide, Cyclosporine, Fludarabine, Mycophenolate Mofetil, Mycophenolate Sodium, Total-Body Irradiation, Treosulfan · Intervention Types: Procedure, Biological, Drug, Drug, Drug, Drug, Drug, Radiation, Drug
Arm B (low dose treosulfan)Experimental Group · 9 Interventions: Allogeneic Hematopoietic Stem Cell Transplantation, Filgrastim, Cyclophosphamide, Cyclosporine, Fludarabine, Mycophenolate Mofetil, Mycophenolate Sodium, Total-Body Irradiation, Treosulfan · Intervention Types: Procedure, Biological, Drug, Drug, Drug, Drug, Drug, Radiation, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Allogeneic Hematopoietic Stem Cell Transplantation
2012
Completed Phase 2
~1280
Filgrastim
FDA approved
Cyclophosphamide
FDA approved
Cyclosporine
FDA approved
Fludarabine
FDA approved
Mycophenolate mofetil
FDA approved
Mycophenolic acid
FDA approved
Total-Body Irradiation
1997
Completed Phase 3
~1220
Treosulfan
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at 1- and 2-years post-transplant

Who is running the clinical trial?

Fred Hutchinson Cancer Research CenterLead Sponsor
443 Previous Clinical Trials
149,202 Total Patients Enrolled
Fred Hutchinson Cancer CenterLead Sponsor
538 Previous Clinical Trials
1,327,230 Total Patients Enrolled
medac GmbHIndustry Sponsor
36 Previous Clinical Trials
8,786 Total Patients Enrolled
Filippo MilanoPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium
6 Previous Clinical Trials
391 Total Patients Enrolled

Eligibility Criteria

Age Any Age · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
If you had a bone marrow transplant done by someone else's cells, you can participate if it was done at least 3 months ago, unless your body rejected the transplant.
References

Frequently Asked Questions

What is the FDA's stance on Allogeneic Hematopoietic Stem Cell Transplantation?

"Allogeneic Hematopoietic Stem Cell Transplantation is still in Phase 2, so there is only preliminary evidence for its safety." - Anonymous Online Contributor

Unverified Answer

What is the primary reason that Allogeneic Hematopoietic Stem Cell Transplantation is employed?

"Allogeneic Hematopoietic Stem Cell Transplantation is the standard care for transplant patients. Additionally, this intervention can be used to treat disorders like multiple sclerosis and lupus nephritis." - Anonymous Online Contributor

Unverified Answer

How many people are part of this experiment?

"The clinicaltrials.gov website verifies that this study is seeking patients. This trial was originally posted on January 25th, 2021 and updated as recently as October 26th, 2022. The investigators need to enroll 60 individuals at a single site." - Anonymous Online Contributor

Unverified Answer

Are there other cases where Allogeneic Hematopoietic Stem Cell Transplantation has been studied?

"A total of 1105 studies are active that involve Allogeneic Hematopoietic Stem Cell Transplantation. Of these, 202 have reached Phase 3 testing. Most of the research taking place for Allogeneic Hematopoietic Stem Cell Transplantation is based in Philadelphia, Pennsylvania; however, there are a total of 31293 locations running trials for this treatment worldwide." - Anonymous Online Contributor

Unverified Answer

Are patients being recruited for this research project at this time?

"Correct, the listing on clinicaltrials.gov says that this research project is open for recruitment. The study was first announced on January 25th 2021 and updated October 26th 2022. They are looking for 60 individuals total from 1 centre." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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