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

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

Eligibility Criteria

Sex

ALL

Age

12 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Anti-Thymocyte Globulin — BIOLOGICAL
  Given IV
• Busulfan — DRUG
  Given IV
• Clofarabine — DRUG
  Given IV
• Cyclophosphamide — DRUG
  Given IV
• Filgrastim-sndz — BIOLOGICAL
  Given SC
• Fludarabine — DRUG
  Given IV
• Melphalan — DRUG
  Given IV
• Mycophenolate Mofetil — DRUG
  Given IV or PO
• Rituximab — BIOLOGICAL
  Given IV
• Tacrolimus — DRUG
  Given IV
• Total-Body Irradiation — RADIATION
  Undergo total body irradiation
• Umbilical Cord Blood Transplantation — PROCEDURE
  Undergo cord blood transplant

Study Details

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.

Key Dates

Start date

Oct 13, 2017

Status verified

Oct 2023

Primary completion

Sep 20, 2022

Completion

Sep 20, 2022

Study Design

Enrollment

6 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Chemotherapy and Cord blood transfusion
  All patients received Busulfan as per standard of care. Busulfan test dose can be administered either as an outpatient prior to admission or as an inpatient on Day -10. Busulfan pharmacokinetics will be performed with the test dose and the first dose on Day -7 per standard of care. The doses of Days -6, -5, and -4 will be subsequently adjusted to target an AUC of 4,000 microMol.min-1. In the event that PK adjusting were not possible a dose of busulfan of 130 mg/m2 will be administered. GVHD PROPHYLAXIS: All patients also receive mycofenolate mofetil IV over 2 hours or PO BID on days -3 with a taper beginning on day 100 in the absence of GVHD, tacrolimus IV or PO starting on day -2 for 6 months in the absence of GVHD, and filgrastim-sndz SC QD starting on day 0 until white blood count begins to recover.

Primary Outcome Measure

Time to Engraftment [ Time Frame: Up to 12 months after transplant ]

Locations (1)

Find similar trials in Houston, TX

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