Reduced-Intensity Conditioning Before Donor Stem Cell Transplant in With High-Risk Hematologic Malignancies

Summary

This phase II trial studies reduced-intensity conditioning before donor stem cell transplant in treating patients with high-risk hematologic malignancies. Giving low-doses of chemotherapy and total-body irradiation before a donor stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) before the transplant may help increase this effect.

Conditions

• Plasma Cell Myeloma
• Polycythemia Vera
• Recurrent Adult Acute Myeloid Leukemia
• Recurrent Childhood Acute Myeloid Leukemia
• Acute Myeloid Leukemia With FLT3/ITD Mutation
• Acute Myeloid Leukemia With Gene Mutations
• Acute Myeloid Leukemia With Inv(3) (q21.3;q26.2); GATA2, MECOM
• Acute Myeloid Leukemia With t(6;9) (p23;q34.1); DEK-NUP214
• Aplastic Anemia
• Chronic Lymphocytic Leukemia
• Refractory Acute Myeloid Leukemia
• Secondary Acute Myeloid Leukemia
• Therapy-Related Acute Myeloid Leukemia
• Chronic Myelogenous Leukemia, BCR-ABL1 Positive
• Chronic Myelomonocytic Leukemia
• Follicular Lymphoma
• Hodgkin Lymphoma
• Myelodysplastic Syndrome
• Myelofibrosis
• Myeloid Leukemia
• Non-Hodgkin Lymphoma

Interventions

DRUG

Fludarabine phosphate

Given IV

DRUG

Busulfan

Given IV

RADIATION

Total-Body Irradiation

Undergo TBI

BIOLOGICAL

Therapeutic Allogeneic Lymphocytes

Undergo DLI

DRUG

Cyclophosphamide

Given IV

PROCEDURE

Allogeneic Hematopoietic Stem Cell Transplantation

Undergo allogeneic PBSCT

PROCEDURE

Peripheral Blood Stem Cell Transplantation

Undergo allogeneic PBSCT

DRUG

Tacrolimus

Given IV

DRUG

Mycophenolate Mofetil

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

Sponsors & Collaborators

• Sidney Kimmel Cancer Center at Thomas Jefferson University

  lead OTHER

Principal Investigators

• Dolores Grosso, RN, CRNP, DNP · Thomas Jefferson University

• Neal Flomenberg, MD · Thomas Jefferson University

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-12-24

Primary Completion

2022-04-15

Completion

2022-12-05

FDA Device

Yes

Countries

• United States

Study Locations