Umbilical Cord Blood Transplant With Added Sugar and Chemotherapy and Radiation Therapy in Treating Patients With Leukemia or Lymphoma

Summary

This phase II trial studies how well an umbilical cord blood transplant with added sugar works with chemotherapy and radiation therapy in treating patients with leukemia or lymphoma. Giving chemotherapy and total-body irradiation before a donor umbilical cord blood transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. The umbilical cord blood cells will be grown ("expanded") on a special layer of cells collected from the bone marrow of healthy volunteers in a laboratory. A type of sugar will also be added to the cells in the laboratory that may help the transplant to "take" faster.

Conditions

• Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
• Acute Biphenotypic Leukemia
• Acute Leukemia
• Acute Lymphoblastic Leukemia
• Acute Lymphoblastic Leukemia in Remission
• Acute Myeloid Leukemia
• Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
• Chemotherapy-Related Leukemia
• Chronic Lymphocytic Leukemia
• Chronic Myelogenous Leukemia, BCR-ABL1 Positive
• Chronic Myelomonocytic Leukemia
• Hodgkin Lymphoma
• Langerhans Cell Histiocytosis
• Minimal Residual Disease
• Myelodysplastic Syndrome
• Myelodysplastic Syndrome With Excess Blasts
• Non-Hodgkin Lymphoma
• Recurrent Hodgkin Lymphoma
• Refractory Acute Lymphoblastic Leukemia
• Refractory Myelodysplastic Syndrome
• Small Lymphocytic Lymphoma
• Therapy-Related Myelodysplastic Syndrome

Interventions

BIOLOGICAL

Anti-Thymocyte Globulin

Given IV

DRUG

Busulfan

Given IV

DRUG

Clofarabine

Given IV

DRUG

Cyclophosphamide

Given IV

BIOLOGICAL

Filgrastim-sndz

Given SC

DRUG

Fludarabine

Given IV

DRUG

Melphalan

Given IV

DRUG

Mycophenolate Mofetil

Given IV or PO

BIOLOGICAL

Rituximab

Given IV

DRUG

Tacrolimus

Given IV

RADIATION

Total-Body Irradiation

Undergo total body irradiation

PROCEDURE

Umbilical Cord Blood Transplantation

Undergo cord blood transplant

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• M.D. Anderson Cancer Center

  lead OTHER

Principal Investigators

• Amanda Olson · M.D. Anderson Cancer Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

12 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-10-13

Primary Completion

2022-09-20

Completion

2022-09-20

FDA Drug

Yes

Countries

• United States

Study Locations