Umbilical Cord Blood Transplantation in Treating Patients With High-Risk Hematologic Cancer

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00003335

First Posted: January 27, 2003

Last Update Posted: March 15, 2012

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

Case Comprehensive Cancer Center

Tracking Information

First Submitted Date ^ICMJE

November 1, 1999

First Posted Date ^ICMJE

January 27, 2003

Last Update Posted Date

March 15, 2012

Start Date ^ICMJE

January 1998

Primary Completion Date

November 2007 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

rates of durable engraftment in patients [ Time Frame: day 42 ]

The primary study end point will be hematologic engraftment. Engraftment is defined as achieving ANC larger than or equal to 500 ul/mm3 of donor origin for three consecutive measurements on different days by day +42.

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00003335 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Event-free survival by clinical and pathological disease assessment [ Time Frame: at disease progression or death ]
incidence of recurrent disease in patients post UCB transplant [ Time Frame: post transplant ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Umbilical Cord Blood Transplantation in Treating Patients With High-Risk Hematologic Cancer

Official Title ^ICMJE

A Pilot Study of Unrelated Umbilical Cord Blood Transplantation in Patients With High Risk Hematologic Malignancies

Brief Summary

RATIONALE: Umbilical cord blood transplantation may allow doctors to give higher doses of chemotherapy or radiation therapy and kill more cancer cells.

PURPOSE: This phase II trial is studying allogeneic umbilical cord blood transplantation to see how well it works when given with chemotherapy or radiation therapy in treating patients with high-risk hematologic cancer.

Detailed Description

OBJECTIVES:

Determine the rates of hematologic and immune reconstitution in patients with high risk hematologic malignancies who are undergoing high dose chemoradiotherapy followed by unrelated umbilical cord blood (UCB) transplantation.
Determine the incidence of graft-versus-host-disease in this setting.
Describe the incidence of recurrent disease in these patients post UCB transplant.
Describe the incidence of serious infections and secondary lymphoproliferative diseases following transplantation with UCB in these patients.
Determine specifically whether larger recipients can be durably engrafted with unrelated UCB, and determine whether nucleated cell or progenitor cell content of the graft is predictive of hematological engraftment.

OUTLINE: Patients may undergo a back-up peripheral blood stem cell collection prior to treatment.

Patients receive 9 fractions of total body irradiation (TBI) on days -9 to -5 followed by melphalan IV for three days on days -4 to -2 and antithymocyte globulin IV or methylprednisolone IV for three days on days -3 to -1. On day 0, patients receive umbilical cord blood infusion. If TBI is not tolerated, busulfan is substituted and administered orally every 6 hours for 4 days on days -8 to -5. Cyclosporine and methylprednisolone begin on day -2 and continue for 6 months.

Patients are followed at least monthly for 1 year, then every 6 months for the second year, and then annually thereafter.

PROJECTED ACCRUAL: There will be a maximum of 48 patients accrued into this study over 4 years.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

Graft Versus Host Disease
Leukemia
Lymphoma
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Diseases

Intervention ^ICMJE

Biological: anti-thymocyte globulin
antithymocyte globulin IV for three days on days -3 to -1
Drug: busulfan
If TBI is not tolerated, busulfan is substituted and administered orally every 6 hours for 4 days on days -8 to -5.
Drug: cyclosporine
Cyclosporine begin on day -2 and continue for 6 months.
Drug: melphalan
melphalan IV for three days on days -4 to -2
Drug: methylprednisolone
Methylprednisolone IV for three days on days -3 to -1. Methylprednisolone begin on day -2 and continue for 6 months.
Procedure: umbilical cord blood transplantation
On day 0, patients receive umbilical cord blood infusion.
Radiation: radiation therapy
9 fractions of total body irradiation (TBI) on days -9 to -5

Study Arms

Not Provided

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2012

Primary Completion Date

November 2007 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

DISEASE CHARACTERISTICS:

Histologically confirmed high risk malignancy including:
- Acute nonlymphocytic leukemia (ANLL) after induction failure, or in first complete remission with high risk features including stem cell or biphenotypic classification (acute myeloid leukemia (AML) M0), erythroleukemia (AML M6), acute megakaryocytic leukemia (AML M7), cytogenic markers indicative of poor prognosis, or failure to achieve complete remission after standard induction therapy
- Acute lymphocytic leukemia (ALL) or ANLL in second or subsequent remission
- Chronic myeloid leukemia (CML) in chronic phase
  - CML with accelerated phase or blast crisis are eligible after reinduction chemotherapy converts disease to chronic phase
- High risk ALL in first complete remission
- Myelodysplastic syndrome with evidence of evolution to acute myeloid leukemia
  - Refractory anemia with excess blasts
  - Refractory anemia with excess blasts in transformation
- Non-Hodgkin's lymphoma (NHL), ANLL, or ALL with recurrent disease after autologous stem cell transplantation
Must also meet all the following conditions:
- No HLA-ABC/DR identical related bone marrow or UCB donor
- No 5/6 antigen matched related bone marrow or UCB donor
- Condition precludes waiting to search and find a donor in the National Marrow Donor Registry
Must have an available serologic matched umbilical cord blood unit in the New York Blood Center's Placental Blood Project
No active CNS disease

PATIENT CHARACTERISTICS:

Age:

Under 55 at time of umbilical cord blood transplantation

Performance status:

Zubrod 0-1
Karnofsky 80-100%

Life expectancy:

At least 3 months

Hematopoietic:

For patients with ALL or ANLL in remission, CML in chronic phase, or NHL without marrow involvement who elect to undergo autologous peripheral blood stem cell collection and storage:
- WBC at least 3,000/mm^3
- Absolute neutrophil count at least 1,000/mm^3
- Platelet count at least 100,000/mm^3

Hepatic:

Bilirubin no greater than 2.0 mg/dL
ALT/AST no greater than 4 times normal

Renal:

Creatinine no greater than 2.0 mg/dL
Creatinine clearance at least 50 mL/min

Cardiovascular:

Normal cardiac function by echocardiogram or radionuclide scan (shortening fraction or ejection fraction at least 80% of normal value for age)

Pulmonary:

FVC and FEV_1 at least 60% of predicted for age
For adults:
- DLCO at least 60% of predicted

Other:

HIV negative
No active infections at time of autologous stem cell harvest or pretransplant cytoreduction
Not pregnant or nursing
Effective contraception required of all fertile patients

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Prior autologous stem cell transplantation allowed

Chemotherapy:

See Disease Characteristics

Endocrine therapy:

Not specified

Radiotherapy:

Not specified

Surgery:

Not specified

Sex/Gender

Sexes Eligible for Study:

All

Ages

up to 54 Years (Child, Adult)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00003335

Other Study ID Numbers ^ICMJE

CWRU4Y97
P30CA043703 ( U.S. NIH Grant/Contract )
NCI-G98-1429
CWRU4Y97 ( Other Identifier: Case Comprehensive Cancer Center )

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Case Comprehensive Cancer Center

Study Sponsor ^ICMJE

Case Comprehensive Cancer Center

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Brenda W. Cooper, MD

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

PRS Account

Case Comprehensive Cancer Center

Verification Date

March 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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