Cord Blood Transplantation for Patients With Cancer

NCT01359254 | Terminated Phase 2 Results

• 1 other identifier: 10-020-B
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to assess the rate of engraftment with combined haploidentical-cord blood transplantation in patients with pre-existing donor specific antibodies and in those with active disease.

Conditions

Hematological Disease

Outcome Measures

Primary Outcomes (1)

• Cord Blood Engraftment by Day 100

  Percent of subjects with cord blood engraftment on or before day 100. Detectable cord blood engraftment should be present by day 100 in at least 50% of patients. As of 44 days post-transplant, only haploidentical donor chimerism achieved in the one patient enrolled in the Fludarabine, melphalan, and ATG arm. There were no cord cells detected for this patient.

  100 days

Secondary Outcomes (1)

• Survival at Day 100

  100 days

Study Arms (2)

Conditioning Regimen I

EXPERIMENTAL

Arm I contains fludarabine, melphalan, and antithymocyte globulin (ATG)

Drug: Melphalan; Drug: Fludarabine; Drug: Antithymocyte Globulin (ATG)

Conditioning Regimen II

EXPERIMENTAL

Arm II contains fludarabine, busulfan, antithymocyte globulin (ATG), and total body irradiation (TBI).

Drug: Fludarabine; Drug: Antithymocyte Globulin (ATG); Drug: Busulfan; Drug: Total Body Irradiation (TBI)

Interventions

Melphalan DRUG

Melphalan is given daily for 2 days, overlapping with the completion of fludarabine.

Also known as: Alkeran, Sarcolysin

Conditioning Regimen I

Fludarabine DRUG

Fludarabine is given through the vein daily for 5 days.

Also known as: fludarabine phosphate, Fludara

Conditioning Regimen I; Conditioning Regimen II

Antithymocyte Globulin (ATG) DRUG

ATG is given every other day for 4 days.

Conditioning Regimen I; Conditioning Regimen II

Busulfan DRUG

Busulfan is given daily for 4 days.

Also known as: Myleran, Busulfex IV

Conditioning Regimen II

Total Body Irradiation (TBI) DRUG

TBI is given twice on the last day.

Conditioning Regimen II

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Relapsed or refractory acute leukemia (myeloid or lymphoid)
• Acute leukemia in first remission at high-risk for recurrence
• Chronic myelogenous leukemia in accelerated phase or blast-crisis
• Chronic myelogenous leukemia in chronic phase
• Recurrent or refractory malignant lymphoma or Hodgkin lymphoma
• Chronic lymphocytic leukemia, relapsed or with poor prognostic features
• Multiple myeloma
• Myelodysplastic syndrome
• Chronic myeloproliferative disease
• Hemoglobinopathies
• Aplastic anemia

You may not qualify if:

• Zubrod performance status \> 2
• Life expectancy is severely limited by concomitant illness
• Patients with severely decreased LVEF or impaired pulmonary function tests
• Estimated Creatinine Clearance \<50 ml/min
• Serum bilirubin\> 2.0 mg/dl or SGPT \>3 x upper limit of normal
• Evidence of chronic active hepatitis or cirrhosis
• HIV-positive
• Patient is pregnant
• Patient or guardian not able to sign informed consent

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Hematologic Diseases

Interventions

Melphalan; fludarabine; fludarabine phosphate; Antilymphocyte Serum; Busulfan; Whole-Body Irradiation

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Immune Sera; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Biological Products; Complex Mixtures; Butylene Glycols; Glycols; Alcohols; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Radiotherapy; Therapeutics; Investigative Techniques

Results Point of Contact

• Title: Andrew Artz, MD, MS
• Organization: The University of Chicago Medicine

aartz@medicine.bsd.uchicago.edu

(773) 834-8980

Study Officials

• Andrew Artz, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2011
• First Posted: May 24, 2011
• Study Start: April 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: June 1, 2012
• Last Updated: April 30, 2015
• Results First Posted: April 30, 2015

Record last verified: 2015-04

Locations

US (1)