Infections

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Neoplasms

Blood and Lymph Conditions

Rare Diseases

Influenza, Human

Leukemia

Hematologic Neoplasms

Hematologic Diseases

Acute Graft Versus Host Disease

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Etoposide

Cytarabine

Fludarabine

Fludarabine phosphate

Decitabine

Etoposide phosphate

Cladribine

Patients receive the study protocol: CLAGE sequential with Flu-Bu as conditioning regimen followed by low-dose decitabine maintenance

Cladribine combined with cytarabine and VP16 sequential with Fludarabine combined with busulifan

CLAGE-FluBu

Junming Li, M.D

For patients with refractory acute leukemia, allogeneic stem cell transplantation is the only curative therapy. Only 20% of patients may achieve long-term survival mostly due to relapse or nor-relapse mortality (NRM). In previous study, we demonstrated that intensive leukemia debulking chemotherapy FLAG-IDA sequential with Flu-BU conditioning is feasible with \~40% long-term survival. In the study, we further modified the chemotherapy with cladribine replacing fludarabine aiming a more potent anti-leukemia effect. Meanwhile, we reduce the dose of busulfan for patients with poor performance status and age over 45 aim to reduce the NRM. All patients will also receive post-transplantation maintenance therapy with low-dose decitabine to prevent relapse.

For patients with refractory acute leukemia, allogeneic stem cell transplantation is the only curative therapy. Only 20% of patients may achieve long-term survival mostly due to relapse or nor-relapse mortality (NRM). In previous study, we demonstrated that intensive leukemia debulking chemotherapy FLAG-IDA sequential with Flu-BU conditioning is feasible with \~40% long-term survival. The most important cause of treatment failures were relapse and non-relpase mortality. The further analysis demonstrated that patients with higher bone marrow blast before allo-HSCT was associated with treatment failure and patients with poor perforce status or age over 45 had increased rate of NRM. To further optimization the protocol, we modified the chemotherapy with cladribine replacing fludarabine aiming a more potent anti-leukemia effect and replace idarubicin with VP-16. All patients will also receive post-transplantation maintenance therapy with low-dose decitabine (5mg/m2 daily for 5 days) to prevent the further reduce the relapse incidence. We anticipate LFS at 1 year should be above 50% and 1-year LFS of 20% is considered unacceptable.

CLAGE Sequential With Flu-Bu Conditioning for Refractory Acute Leukemia

Cladribine With Intermediate Cytarabine, G-CSF and VP16 Sequential With Fludarabine and Busulifan as Condoning Regimen for Refractory Acute Leukemia

From enrollment to any event as relapse or death

From enrollment to documentation of relapse

From enrollment to documentation of death without evidence of leukemia

Shanghai Jiao Tong University School of Medicine

Head, Blood & Marrow Transplantation program

Tablets, Oral, QD x 14 days until MTD is achieved, 14 days per 28 day cycle/QD, 12 months

Cdc7-inhibitor (BMS-863233)

Tablets, Oral, MTD of Cdc7-inhibitor (A) Arm, QD x 7 days until MTD achieved, 7 days per 21 day cycle/QD, 12 months

Bristol-Myers Squibb

To determine safety, tolerability and maximum tolerated dose of BMS-63233/XL413 in subjects with Refractory Hematologic Cancer

A Study of BMS-863233 in Patients With Hematologic Cancer

A Phase 1/2, Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-863233 in Subjects With Refractory Hematologic Malignancies

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
CLAGE Sequential With Flu-Bu Conditioning for Refractory Acute Leukemia	NCT03882203	Refractory Hema... Allogeneic Stem...	CLAGE-FluBu	16 Years - 60 Years	Shanghai Jiao Tong University School of Medicine
CLAGE Sequential With Flu-Bu Conditioning for Refractory Acute Leukemia	NCT03882203	Refractory Hema... Allogeneic Stem...	CLAGE-FluBu	16 Years - 60 Years	Shanghai Jiao Tong University School of Medicine
A Study of BMS-863233 in Patients With Hematologic Cancer	NCT00838890	Refractory Hema...	Cdc7-inhibitor ... Cdc7-inhibitor ...	18 Years -	Bristol-Myers Squibb
A Study of BMS-863233 in Patients With Hematologic Cancer	NCT00838890	Refractory Hema...	Cdc7-inhibitor ... Cdc7-inhibitor ...	18 Years -	Bristol-Myers Squibb

Spots Global Cancer Trial Database for refractory hematologic cancer