RECRUITING

Allo HSCT Using RIC and PTCy for Hematological Diseases

Description

This is a Phase II study following subjects proceeding with our Institutional non-myeloablative cyclophosphamide/ fludarabine/total body irradiation (TBI) preparative regimen followed by a related, unrelated, or partially matched family donor stem cell infusion using post-transplant cyclophosphamide (PTCy), sirolimus and MMF GVHD prophylaxis.

Conditions

Acute Myelogenous LeukemiaAcute Lymphocytic LeukemiaBiphenotypic Acute LeukemiaUndifferentiated LeukemiaProlymphocytic LeukemiaChronic Myelogenous LeukemiaPlasma Cell LeukemiaMyelodysplastic SyndromesLeukemia, MyeloidMyelodysplastic Syndrome With Excess Blasts-1Burkitt LymphomaRelapsed T-Cell LymphomaRelapsed Chronic Lymphocytic LeukemiaSmall Lymphocytic LymphomaMarginal Zone LymphomaFollicular LymphomaMyeloproliferative NeoplasmMyelofibrosis
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Related Conditions:

Acute Myelogenous LeukemiaAcute Lymphocytic LeukemiaBiphenotypic Acute LeukemiaUndifferentiated LeukemiaProlymphocytic LeukemiaChronic Myelogenous LeukemiaPlasma Cell LeukemiaMyelodysplastic SyndromesLeukemia, MyeloidMyelodysplastic Syndrome With Excess Blasts-1Burkitt LymphomaRelapsed T-Cell LymphomaRelapsed Chronic Lymphocytic LeukemiaSmall Lymphocytic LymphomaMarginal Zone LymphomaFollicular LymphomaMyeloproliferative NeoplasmMyelofibrosis

Study Overview

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Study Details

Study overview

This is a Phase II study following subjects proceeding with our Institutional non-myeloablative cyclophosphamide/ fludarabine/total body irradiation (TBI) preparative regimen followed by a related, unrelated, or partially matched family donor stem cell infusion using post-transplant cyclophosphamide (PTCy), sirolimus and MMF GVHD prophylaxis.

Allogeneic Hematopoietic Stem Cell Transplantation Using Reduced Intensity Conditioning (RIC) With Post-Transplant Cytoxan (PTCy) for the Treatment of Hematological Diseases

Allo HSCT Using RIC and PTCy for Hematological Diseases

Condition
Acute Myelogenous Leukemia
Intervention / Treatment

-

Contacts and Locations

Minneapolis

Masonic Cancer Center at University of Minnesota, Minneapolis, Minnesota, United States, 55455

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Age 0 to 75 years of age with Karnofsky score ≥ 70% (≥ 16 years) or Lansky score ≥ 50 (\< 16 years).
  • * 5/6 or 6/6 related donor, OR a 7-8/8 HLA-A, B, C, DRB1 allele match, OR a haplotype (at least 5/10) matched related donor. Donors will be requested to provide PBSCs although bone marrow is acceptable according to donor preference.
  • * t(8,21) without cKIT mutation
  • * inv(16) or t(16;16) without cKIT mutation
  • * Normal karyotype with mutated NPM1 and wild type FLT-ITD (unless persistently NPM1 positive by PCR following two cycles of chemotherapy)
  • * Normal karyotype with double mutated CEBPA
  • * Acute prolymphocytic leukemia (APL) in first molecular remission at the end of consolidation
  • * Evidence of high risk cytogenetics, e.g. t(9;22), t(1;19), t(4;11), other MLL rearrangements, IKZF1
  • * 30 years of age or older at diagnosis
  • * White blood cell counts of greater than 30,000/mcL (B-ALL) or greater than 100,000/mcL (T-ALL) at diagnosis
  • * CNS leukemia involvement during the course of disease
  • * Slow cytologic response (\>10% lymphoblasts in bone marrow on Day 14 of induction therapy)
  • * Evidence of persistent immonophenotypic or molecular minimal residual disease (MRD) at the end of induction and consolidation therapy.
  • * Pregnant or breast feeding. The agents used in this study include Pregnancy Category D: known to cause harm to a fetus. Females of childbearing potential must have a negative pregnancy test prior to starting therapy.
  • * Untreated active infection
  • * Active central nervous system malignancy
  • * CML in blast crisis
  • * Intermediate or high grade NHL, mantle cell NHL, and Hodgkin disease that is progressive on salvage therapy. Stable disease is acceptable to move forward provided it is non-bulky.
  • * Less than 3 months since prior myeloablative transplant
  • * Evidence of progressive disease by imaging modalities or biopsy - persistent PET activity, though possibly related to lymphoma, is not an exclusion criterion in the absence of CT changes indicating progression.

Ages Eligible for Study

to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Masonic Cancer Center, University of Minnesota,

Mark Juckett, PRINCIPAL_INVESTIGATOR, University of Minnesota Masonic Cancer Center

Study Record Dates

2028-10-22