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methotrexate

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mitoxantrone hydrochloride

prednisone

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allogeneic hematopoietic stem cell transplantation

autologous hematopoietic stem cell transplantation

peripheral blood stem cell transplantation

radiation therapy

Roberto Foa, MD

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. When the healthy stem cells are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Giving combination chemotherapy together with imatinib mesylate and peripheral stem cell transplant may be an effective treatment for acute lymphoblastic leukemia.

Nevertheless, in the last few years GIMEMA has pubblished a paper in which 100% of Ph+ ALL patients reach HCR only with Imatinib, without any chemiotherapy. Thus, this treatment will be implemented in patients pertaining to this category.

Chemotherapy With or Without Imatinib and/or Peripheral Stem Cell Transplant in Acute Lymphoblastic Leukemia

Phase II Study of Adult Acute Lymphoblastic Leukaemia (ALL): Imatinib in Combination With Chemotherapy in Ph+ Patients, and Post-remissional Treatment Intensification in High-risk Ph- Patients, With Minimal Residual Disease Monitoring.

Gruppo Italiano Malattie EMatologiche dell'Adulto

Only serious adverse events are reported.

In this protocol, adult Philadelphia positive acute lymphoblastic leukemia patients were treated with chemotherapy for induction and consolidation, followed by maintenance with imatinib. The protocol was subsequently amended and imatinib was incorporated in the induction and post-remission phase together with chemotherapy. Due to the toxicity of this combined approach, the protocol was further amended to a sequential scheme based on imatinib plus steroids as induction, followed by consolidation with chemotherapy plus imatinib and, when applicable, by a hematopoietic stem cell transplant.

Thus, we have analyzed only this subset of patients as it was not feasible to analyzed all patients enrolled due also to the disease itself.

Philadelphia Positive, Imatinib Only in Induction Therapy

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

Italy

Region of Enrollment

White Blood Cells (WBC) at diagnosis-nsr

p190

p210

p190/p210

BCR transcript-molecular at diagnosis

Non responder-blasts reduction <75%

Responder-blasts reduction >=75%

Frequency missing

Pre-treatment response

Alfonso Piciocchi

Percentage of Participants Reaching Disease Free Survival

Number of Patients Reaching Complete Hematological Response After Induction Therapy

Percentage of Participants Reaching Overall Survival

These subset of patients was treated according to amendment three, in which Imatinib was given only at induction.

Overall Study

Recurrence

Leukemia, Myeloid

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Blast Crisis

Myeloid Leukemia

Chronic Graft Versus Host Disease

Chronic Myeloid Leukemia

Anti-Arrhythmia Agents

Vasodilator Agents

Pentostatin

Cordycepin

Adenosine

Clotrimazole

Miconazole

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Dose escalation for deoxycoformycin and cordycepin

Dose escalation study using the following doses:

6mg/m2, 12 mg/m2, 24mg/m2, 48mg/m2

Dose escalation using the Fibonacci dose escalation sequence starting dose 2mg/m2, escalating to 3mg/m3 intravenous

Deoxycoformycin

Timothy J. Ernst, MD

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of chemotherapy consisting of cordycepin plus pentostatin in treating patients with refractory acute lymphocytic or chronic myelogenous leukemia.

OBJECTIVES: I. Evaluate the safety, maximum tolerated dose, adverse effects, and toxicities of cordycepin, given 1 hour following a fixed dose of the adenosine deaminase inhibitor pentostatin, in patients with refractory TdT positive leukemia. II. Determine the single and multiple dose pharmacokinetics of cordycepin given 1 hour following a fixed dose of pentostatin. III. Characterize selected whole blood and blast cell metabolic parameters serially in relation to cordycepin/pentostatin administration. IV. Measure and quantify any clinical responses in refractory TdT positive leukemia patients following cordycepin/pentostatin administration.

OUTLINE: This is a dose escalation study. Each treatment course is 28 days in length. On days 1-3 pentostatin is administered over 5 minutes by IV bolus and followed 1 hour later by a 1 hour infusion of cordycepin IV. An escalating dose of pentostatin is given with a fixed dose of cordycepin until the desired level of adenosine deaminase inhibition is observed. After this is determined, a dose escalation schedule for cordycepin is initiated to determine the maximum tolerated dose (MTD) when given in combination with pentostatin. The MTD is determined by the number of patients who exhibit dose limiting toxicity and the severity of the toxicity.

PROJECTED ACCRUAL: Approximately 30 patients will be accrued.

Chemotherapy With Cordycepin Plus Pentostatin in Treating Patients With Refractory Acute Lymphocytic or Chronic Myelogenous Leukemia

A Phase I Study of Cordycepin (NSC 63984) Plus 2'-Deoxycoformycin (NSC 218321) in Patients With Refractory TdT-Positive Leukemia

Dose limiting toxicities will be assessed within the first 28 days of study drug

National Cancer Institute (NCI)

Boston Medical Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Chemotherapy With or Without Imatinib and/or Peripheral Stem Cell Transplant in Acute Lymphoblastic Leukemia	NCT00458848	Leukemia	asparaginase daunorubicin hy... etoposide idarubicin imatinib mesyla... mercaptopurine methotrexate methylprednisol... mitoxantrone hy... prednisone vincristine sul... allogeneic hema... autologous hema... peripheral bloo... radiation thera...	15 Years - 60 Years	Gruppo Italiano Malattie EMatologiche dell'Adulto
Chemotherapy With Cordycepin Plus Pentostatin in Treating Patients With Refractory Acute Lymphocytic or Chronic Myelogenous Leukemia	NCT00003005	Leukemia	Cordycepin Deoxycoformycin	18 Years -	Boston Medical Center

Spots Global Cancer Trial Database for tdt positive adult acute lymphoblastic leukemia