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Fludarabine/Busulfan and Cyclophosphamide Conditioning for Adult Acute Lymphocytic Leukemia Patients Undergoing Allogeneic Stem Cell Transplantation

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Shanghai Jiao Tong University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Jiong HU, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT01435447
First received: September 14, 2011
Last updated: August 28, 2014
Last verified: June 2014
  Purpose

Allogeneic stem cell transplantation is potential curative therapy for adult acute lymphocytic leukemia (ALL). Based on our previous study, the condition with iv-busulfan (iv-BU) and cyclophosphamide (CTX) is feasible with low toxicity and transplantation mortality and long-term survival is comparable to most data reported with slightly higher relapse rate particularly for patients in CR2. In this study, the investigators aim to further improve the conditioning with Fludarabine + iv-BU and to use CTX after stem cell transfusion as consolidation for ALL and graft-versus-host disease (GVHD) prophylaxis.


Condition Intervention Phase
Acute Lymphocytic Leukemia
Drug: FLu-Bu-Cy (Fludarabine/Busulfan and Cyclophosphamide)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Shanghai Jiao Tong University School of Medicine:

Primary Outcome Measures:
  • overall survival [ Time Frame: 3-year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • transplantation related mortality [ Time Frame: 3-year ] [ Designated as safety issue: Yes ]
  • relapse rate [ Time Frame: 3-year ] [ Designated as safety issue: No ]
  • overall -survival [ Time Frame: day 100 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: April 2011
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FLu-Bu-Cy (Fludarabine/Busulfan and Cyclophosphamide) Drug: FLu-Bu-Cy (Fludarabine/Busulfan and Cyclophosphamide)
Fludarabine at 30mg/m2 daily followed by iv-Busulfan at 3.2mg/kg daily for a total of 4 days from Day-6 to -3 and cyclophosphamide as 60mg/kg daily for 2 days on Day +3 and +4, CSA 3mg/kg starting after D+5.

Detailed Description:

Patients with adult acute lymphocytic leukemia (ALL) received conditioning with Fludarabine + iv-BU. The GVHD was consisting of D+3 and D+4 CTX after stem cell transfusion. CSA will be added for all patients after D+5.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult acute lymphocytic leukemia in 1st or second remission
  • age 18-60 years
  • with inform consent
  • no contraindication for allogeneic transplantation: active infection, allergy to FLu/Bu/CTX, liver and renal function damage
  • HLA matched related (6/6), unrelated donors (at least 8/10) or mismatched related donor (haplo)

Exclusion Criteria:

  • age less than 18 years or over 60 years
  • liver function/renal function damage (over 2 X upper normal range)
  • with mental disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01435447

Contacts
Contact: Jiong HU, M.D. 86-21-64370045 ext 601878 hujiong@medmail.com.cn
Contact: Tang Wei, M.D. 86-21-64370045 ext 601816 weiwei_tang@yaoo.com

Locations
China, Shanghai
Blood and Marrow Transplantation Center, Rui Jin Hospital Recruiting
Shanghai, Shanghai, China, 200025
Contact: Jiong HU, M.D.    86-21-64370045 ext 601878    hujiong@medmail.com.cn   
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
  More Information

No publications provided

Responsible Party: Jiong HU, Head, Blood and Marrow Transplantation Center, Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT01435447     History of Changes
Other Study ID Numbers: RJH-ALL-2011
Study First Received: September 14, 2011
Last Updated: August 28, 2014
Health Authority: China: Shanghai JiaoTong University School of Medicine

Keywords provided by Shanghai Jiao Tong University School of Medicine:
efficacy
safety
conditioning
fludarabine
busulfan
cyclophosphamide
adult

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Busulfan
Cyclophosphamide
Fludarabine
Fludarabine phosphate
Alkylating Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014