Cyclophosphamide Plus T-Cell Transplantation for Patients... | NCT00356928

Studies
Cyclophosphamide Plus T-Cell Transplantation for Patients With Hematologic Malignancies

NCT00356928

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Status

Terminated

Last Update Posted

Aug 20, 2018Actual

Enrollment

14Actual

Phase

Phase 1

Conditions

Leukemia
Myelodysplastic Syndromes

Interventions

Cyclophosphamide
Donor T cells

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R21CA121588	U.S. NIH Grant/Contract		View source
P30CA006973	U.S. NIH Grant/Contract		View source
NA_00000901	Other Identifier	JHMIRB

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Poor accrual

Expanded Access Info

Start Date

Oct 2006Actual

Primary Completion Date

May 2011Actual

Completion Date

May 2011Actual

First Submitted Date

Jul 26, 2006

First Submission Date that Met QC Criteria

Jul 26, 2006

First Posted Date

Jul 27, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 16, 2018

Last Update Posted Date

Aug 20, 2018Actual

Name	Class
National Cancer Institute (NCI)	NIH

Description Module

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of abnormal blood cells, either by killing the cells or by stopping them from dividing. Giving cyclophosphamide together with donor lymphocytes that have been treated in the laboratory may be an effective treatment for myelodysplastic syndromes or myeloproliferative disorders.

PURPOSE: This clinical trial is studying the best dose of donor lymphocytes when given together with cyclophosphamide in treating patients with myelodysplastic syndromes or myeloproliferative disorders.

Detailed Description

OBJECTIVES:

Determine the maximum tolerated dose of allogeneic CD8-positive T-cell-depleted, haploidentical donor lymphocytes when given after cyclophosphamide in patients with myelodysplastic syndromes or myeloproliferative disorders.

OUTLINE: Patients receive cyclophosphamide on days 1 and 2. Patients then undergo infusion of allogeneic T-cell depleted donor lymphocytes on day 3.

Cohorts of patients receive escalating doses of CD8-positive T-cell-depleted haploidentical donor lymphocytes until the maximum tolerated dose is determined.

PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

14Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cyclophosphamide + T cells	Experimental	Conditioning regimen with cyclophosphamide followed by donor T cells on Day 0.	Drug: Cyclophosphamide Biological: Donor T cells

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cyclophosphamide	Drug	50 mg/kg/day intravenously (IV) on Days -2 and -1.	Cyclophosphamide + T cells

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maximum tolerated dose of haploidentical donor lymphocytes	Maximum dose in cells per kilogram that did not cause dose-limiting toxicity (defined as grade 3-5 non-hematologic toxicity, death within 60 days related to protocol treatment, aplasia related to treatment, or grade 3-4 graft-vs-host-disease).	60 days

Secondary Outcomes

Measure	Description	Time Frame
Disease response	Percentage of participants who had a complete remission after protocol treatment.	Up to 6 months
Duration of response	Median length of response (in months) of participants who had a complete remission after protocol treatment.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

DISEASE CHARACTERISTICS:

Diagnosis of 1 of the following:
- Myelodysplastic syndromes (MDS)
  - International Prognostic Scoring System (IPSS) score ≥ intermediate-2
- Chronic myelomonocytic leukemia
- Acute myeloid leukemia arising from MDS
Must have failed or are ineligible for or intolerant to treatment with azacitidine
- Patients with normal marrow cytogenetics or an isolated 5q- abnormality must have failed or are ineligible for or intolerant to treatment with lenalidomide
- Patients who are HLA-DR15-positive must have failed or are ineligible for pharmacologic immunosuppression (e.g., anti-thymocyte globulin, cyclosporine, steroids)
No presence of cytotoxic antibodies against donor lymphocytes
No HLA-identical donor available OR ineligible for HLA-identical allogeneic bone marrow transplantation
HLA partially mismatched (haploidentical) related donor available
- First-degree related donor, including half-siblings or first cousins
- Inherited recombinant haplotype from parents allowed if donor shares ≥ 1 HLA antigen at each of the HLA-A, -B, and DR loci

PATIENT CHARACTERISTICS:

ECOG performance status (PS) 0-1 OR Karnofsky PS 80-100%
Bilirubin < 3.0 mg/dL
AST and ALT ≤ 4 times upper limit of normal
Creatinine < 3.0 mg/dL
LVEF > 35%

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
Recovered from prior therapy
No prior transfusions from donor
At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) or radiotherapy
No other concurrent investigational drugs

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

120 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

ID	Term
D010752	Phosphoramide Mustards
D009588	Nitrogen Mustard Compounds
D009150	Mustard Compounds
D006846	Hydrocarbons, Halogenated

ID	Term
D007938	Leukemia
D009190	Myelodysplastic Syndromes
D015477	Leukemia, Myelomonocytic, Chronic