Sequential Intensive Chemotherapy Followed by RIC for Refractory and Relapse ALL

Shanghai Jiao Tong University School of Medicine

Status and phase: Unknown; Phase 2

Conditions: Lymphoblastic Leukemia, Acute, Adult

Treatments: Drug: FACE-Flu/Bu/Cy

Study type: Interventional

Funder types: Other

Identifiers

NCT02766868

RJH-2015-RefactoryALL-SCT

Details and patient eligibility

About

Patients with refractory and relapse lymphoblastic leukemia had poor outcome even with marrow ablative conditioning mostly standard iv-Bu-Cy or Cy-TBI. In this study, we focus on a new treatment strategy with high-dose chemotherapy regimen consisting of fludaraibine+cytarabine+cyclophosphamide+etoposide followed by reduced intensity condiotning regimen consisting of fludarabine, busulfan and post-infusion cyclophophamide.

Full description

All patients with refractory and relapse lymphoblastic leukemia will receive a high-dose chemotherapy regimen consisting of fludaraibine+cytarabine+ cyclophosphamide+etoposide. At day 7 after chemo, a bone marrow aspiration and MRD study by flow-cytometry is planned. For those patients with no residual blasts will undergo allogeneic stem cell transplantation with reduced intensity condiotning regimen consisting of 5-day fludarabine and 3-day busulfan and post-infusion cyclophophamide (D+3 and +4) as GVHD prophylaxis.

Enrollment: 20 estimated patients

Sex: All

Ages: 16 to 59 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients with refractory or relapse acute lymphoblastic leukemia not in remission after 2 cycles of induction chemotherapy early relapse (1st remission less than 6 months) not in remission after 1 cycle of re-induction chemotherapy multiple relapse
• age 16-60 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 (8~10/10) or haplo

Exclusion criteria

• liver function/renal function damage (over 2 X upper normal range)
• mental disease

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

FACE-Flu/Bu/Cy

Experimental group

Description:

Chemotherapy with Fludarabine+cytarabine+cyclophosphamide+etoposie followed by conditioning regimen with Fludarabine, busulfan and Cyclophosphamide

Treatment:

Drug: FACE-Flu/Bu/Cy