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The investigators focused on patients with refractory acute leukemia or MDS and designed a phase 1 trial of escalated cladribine doses in the Cla-Flu-Bu RTC regimen using PK-guided myeloablative busulfan doses. This scheme allows combining different optimization of RTC experienced over years (Flu-Bu RTC, PK-guided myeloablative busulfan doses, a second purine analog cladribine) to approach a specific platform to treat refractory diseases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fludarabine-Cladribine-Busulfan conditioning regimen | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fludarabine-Cladribine-Busulfan conditioning regimen | Drug | Conditioning regimen will be performed from day -6 to day -2 and contains:
|
| Measure | Description | Time Frame |
|---|---|---|
| estimation of the maximal tolerable dose,if any,and recommended phase II dose of cladribine administered as in combination with fludarabine and PK-guided IV busulfan prior Allo-HSCT for refractory acute leukemia and myelodysplastic syndrome (MDS) | Occurrence ratio of dose-limiting toxicity defined as any grade ≥ 3 toxicity according to CTCAE (version 4.03 ) attributable to conditioning regimen (extra-medullary toxicity), considered to be related or probably related to the Cla-Fu-Bu RTC by the investigator. | 30 days after Allo-HSCT |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative incidence of acute Graft versus host disease | Cumulative incidence of acute Graft versus host disease according to Gluckberg's classification | 100 days |
| Cumulative incidence of chronic Graft versus host disease |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dominique Genre, MD | Contact | +33491223778 | drci.up@ipc.unicancer.fr | |
| Jihane Pakradouni, PharmD, PhD | Contact | +33491223778 | drci.up@ipc.unicancer.fr |
| Name | Affiliation | Role |
|---|---|---|
| Raynier Devillier, MD,PhD | Institut Paoli-Calmettes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Paoli-Calmettes | Recruiting | Marseille | Bouches-du-Rhône | 13009 | France |
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|
Cumulative incidence of chronic Graft versus host disease according to NIH classification
| 1 year |
| Cumulative incidence of relapse | Cumulative incidence of relapse at 1 year | 1 year |
| Cumulative incidence of Non Relapse Mortality | Cumulative incidence of Non Relapse Mortality at day +100 and 1 year after Allo-HSCT | 100 days, 1 year |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D001855 | Bone Marrow Diseases |
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