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Reduced Toxicity Fludarabine, Cyclophosphamide Plus Thymoglobulin Conditioning Regimen for Unrelated Donor Transplantation in Severe Aplastic Anemia

Reduced Toxicity Fludarabine (Flu) + Cyclophosphamide (CPM) + Rabbit Antithymocyte Globulin (rATG) Conditioning Regimen for Unrelated Donor Transplantation in Severe Aplastic Anemia (SAA)



Sponsors

Lead Sponsor

 The Korean Society of Pediatric Hematology Oncology


Source

The Korean Society of Pediatric Hematology Oncology

Oversight Info

Has Dmc

Yes


Brief Summary

Anti-thymocyte globulin (ATG) has been used in severe aplastic anemia as a part of the conditioning regimen. Among the many kinds of ATG preparations, thymoglobulin had been found to be more effective in preventing graft versus host disease (GVHD) and rejection of organ transplants. As the fludarabine based conditioning regimens without total body irradiation have been reported to be promising for transplantation from alternative donors in SAA, thymoglobulin was added to fludarabine and cyclophosphamide conditioning to reduce GVHD and to allow good engraftment in unrelated donor transplantation. Our previous phase II study of fludarabine, cyclophosphamide plus thymoglobulin conditioning resulted in good engraftment (100%) and survival rate (74%). But grade III/IV toxicities occurred in 25% of patients and all events were treatment related mortalities. As cyclophosphamide is more toxic agent than fludarabine, we plan a new phase II study re; 'reduced toxicity fludarabine, cyclophosphamide plus thymoglobulin conditioning regimen for unrelated donor transplantation in severe aplastic anemia' by reducing dosage of cyclophosphamide and increasing dosage of fludarabine.

Overall Status

Unknown status

Start Date

2008-11-01

Completion Date

2012-10-01

Primary Completion Date

2012-10-01

Phase

Phase 2

Study Type

Interventional

Primary Outcome

Measure

Time Frame

To evaluate engraftment potential of reduced toxicity fludarabine, cyclophosphamide plus thymoglobulin conditioning regimen for unrelated bone marrow transplantation in severe aplastic anemia.
From Nov. 2008 to Oct. 2012

Secondary Outcome

Measure

Time Frame

To evaluate toxicities of reduced toxicity fludarabine, cyclophosphamide plus thymoglobulin conditioning regimen for UBMT/PBSCT in SAA.
From Nov. 2008 to Oct. 2012
To evaluate overall and EFS rate after UBMT/PBSCT.
From Nov. 2008 to Oct. 2012
To evaluate GVHD and immunologic recovery after UBMT/PBSCT.
From Nov. 2008 to Oct. 2012

Enrollment

33

Condition

 Aplastic Anemia

Intervention

Intervention Type

Drug

Intervention Name

 Cyclophosphamide,   Fludarabine,   Thymoglobulin

Description

cyclophosphamide (60 mg/kg once daily i.v. on days -8, -7) fludarabine (40 mg/m2 once daily i.v. on days -6, -5, -4, -3, -2) thymoglobulin (2.5 mg/kg once daily i.v. on days -4, -3, -2)

Arm Group Label

Fludarabine


Eligibility

Criteria

Inclusion Criteria: 1. Diagnosis of severe aplastic anemia defined by any two or three peripheral blood criteria and either marrow criterion. - Peripheral blood 1. Neutrophils < 0.5 x 109/l 2. Platelets < 20 x 109/l 3. Corrected reticulocytes < 1% - Bone marrow 1. Severe hypocellularity (< 25%) 2. Moderate hypocellularity (25-30%) with hematopoietic cells representing < 30% of residual cells 2. No prior hematopoietic stem cell transplantation. 3. Age: no limits. 4. Performance status: ECOG 0-2. 5. Patients must be free of significant functional deficits in major organs, but the following eligibility criteria may be modified in individual cases: - Heart: a shortening fraction > 30% and ejection fraction > 45%. - Liver: total bilirubin < 2 × upper limit of normal; ALT < 3 × upper - Kidney: creatinine <2 × normal or a creatinine clearance (GFR) > 60 ml/min/1.73m2. 6. Patients must lack any active viral infections or active fungal infection. 7. Appropriate donor is available: Matched in 6/6 of A, B, DR loci. 8. Patients (or one of parents if patients age < 19) should sign informed consent. Exclusion Criteria: 1. Pregnant or nursing women. 2. Malignant or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy. 3. Psychiatric disorder that would preclude compliance. 4. Congenital aplastic anemia including Fanconi anemia. 5. Manipulated bone marrow.

Gender

All

Minimum Age

1 Year

Maximum Age

21 Years

Healthy Volunteers

No


Overall Official

Last Name

Role

Affiliation

Hyo seop Ahn, M.D, Ph. D
Principal Investigator
The Korean Society of Pediatric Hematology Oncology

Overall Contact

Last Name

Hyoung Jin Kang, M.D, Ph.D

Phone

82 2 2072 3304

Email

[email protected]


Location

Facility

Status

Contact

Seoul National University Hospital
Seoul 110-744 Korea, Republic of
Recruiting
Last Name: Hyo Seop Ahn, M.D, Ph.D
Phone: 82 2 2072 3625
Email: [email protected]

Location Countries

Country

Korea, Republic of


Verification Date

2012-03-01

Lastchanged Date

N/A

Firstreceived Date

N/A

Responsible Party

Name Title

The Korean Society of Hematology

Organization

The Korean Society of Pediatric of Hematology Oncology


Has Expanded Access

No

Condition Browse

 Anemia,  Anemia, Aplastic

Number Of Arms

1

Intervention Browse

Mesh Term

Cyclophosphamide

Fludarabine phosphate

Thymoglobulin

Antilymphocyte Serum

Fludarabine

Vidarabine



Arm Group

Arm Group Label

Fludarabine

Arm Group Type

Experimental


Firstreceived Results Date

N/A

Overall Contact Backup

Last Name

Ji Won Lee, M.D

Phone

82 2 2072 0177

Email

[email protected]


Firstreceived Results Disposition Date

N/A

Study Design Info

Intervention Model

Parallel Assignment

Primary Purpose

Treatment

Masking

None (Open Label)


Study First Submitted

April 15, 2009

Study First Submitted Qc

April 15, 2009

Study First Posted

April 16, 2009

Last Update Submitted

March 23, 2012

Last Update Submitted Qc

March 23, 2012

Last Update Posted

March 26, 2012

Last Known Status

Recruiting


ClinicalTrials.gov processed this data on August 28, 2018

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Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.

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