Fludarabine/Busulfan and Cyclophosphamide Conditioning for Adult ALL

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01435447
Recruitment Status : Recruiting
First Posted : September 16, 2011
Last Update Posted : May 10, 2016
Information provided by (Responsible Party):
Jiong HU, Shanghai Jiao Tong University School of Medicine

Brief Summary:
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 or disease Intervention/treatment Phase
Acute Lymphocytic Leukemia Drug: FLu-Bu-Cy Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fludarabine/Busulfan and Post-infusion Cyclophosphamide as Conditioning for Adult Patients With ALL Undergoing Allogeienc Stem Cell Transplantation
Study Start Date : April 2011
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : June 2017

Arm Intervention/treatment
Experimental: FLu-Bu-Cy
Patients received Fludarabine and iv Busulfan and post-infusion Cyclophosphamide as conditioning
Drug: FLu-Bu-Cy
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.
Other Name: Study group

Primary Outcome Measures :
  1. overall survival [ Time Frame: 3-year ]

Secondary Outcome Measures :
  1. transplantation related mortality [ Time Frame: 3-year ]
  2. relapse rate [ Time Frame: 3-year ]
  3. overall -survival [ Time Frame: day 100 ]

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01435447

Contact: Jiong HU, M.D. 86-21-64370045 ext 601878
Contact: Tang Wei, M.D. 86-21-64370045 ext 601816

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   
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Principal Investigator: Jiong Hu, m.D. Rui Jin Hospital, Shanghai JiaoTong University School of Medicine

Responsible Party: Jiong HU, Head, Blood and Marrow Transplantation Center, Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine Identifier: NCT01435447     History of Changes
Other Study ID Numbers: RJH-ALL-2011
First Posted: September 16, 2011    Key Record Dates
Last Update Posted: May 10, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jiong HU, Shanghai Jiao Tong University School of Medicine:

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