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A Phase I Study of SJG-136 in Patients With Advanced Leukemia

Phase 1
18 Years
Open (Enrolling)
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Blastic Phase Chronic Myelogenous Leukemia, de Novo Myelodysplastic Syndromes, Previously Treated Myelodysplastic Syndromes, Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Adult Acute Myeloid Leukemia, Refractory Chronic Lymphocytic Leukemia, Relapsing Chronic Myelogenous Leukemia, Secondary Acute Myeloid Leukemia, Secondary Myelodysplastic Syndromes

Thank you

Trial Information

A Phase I Study of SJG-136 in Patients With Advanced Leukemia


I. Establish the maximum tolerated dose of SJG-136 in patients with relapsed or refractory
acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL) myelodysplastic syndrome
(MDS), chronic myelogenous leukemia in blastic phase (CML-BP), or chronic lymphocytic
leukemia (CLL).

II. Determine dose-limiting toxicities and pharmacokinetics of this drug in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive SJG-136 IV over 15 minutes on days 1-5. Courses repeat every 21 days in the
absence of unacceptable toxicity or disease progression.

Cohorts of 3-6 patients receive escalating doses of SJG-136 until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6
patients experience dose-limiting toxicity. A total of 10 patients are treated at the MTD.

Inclusion Criteria:

- Diagnosis of 1 of the following hematologic malignancies:

- Acute myeloid leukemia

- Acute lymphoblastic leukemia

- Myelodysplastic syndromes

- Chronic myelogenous leukemia in blastic phase

- Chronic lymphocytic leukemia

- Relapsed or refractory disease

- No immediately available, potentially curable options (e.g., stem cell
transplantation) available

- Bilirubin normal (unless elevated due to Gilbert's syndrome)

- HIV positivity allowed provided CD4 counts are normal with no AIDS-defining disease

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No uncontrolled intercurrent illness including, but not limited to, any of the

- Ongoing or active infection

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Cardiac arrhythmia

- Psychiatric illness or social situations that would limit study compliance

- Recovered from prior therapy

- ECOG performance status =< 2

- SGOT and SGPT =< 2.5 times upper limit of normal (ULN)

- Creatinine normal OR creatinine clearance >= 60 mL/min

- Primary resistance (i.e., failed to achieve a complete remission [CR] to a standard
induction regimen) or relapsed after achievement of a CR.

- Must have documented failure to last cytotoxic regimen prior to study entry.

- Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

- No known CNS disease

- No history of allergic reactions attributed to compounds of similar chemical or
biologic composition to SJG-136

- More than 7 days since radiotherapy

- No concurrent combination antiretroviral therapy for HIV-positive patients

- No other anti-leukemia agents except hydroxyurea =< 5 grams/day =< 14 days prior to
and during first course of treatment to control blood counts

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose (MTD) determined according to dose-limiting toxicities (DLTs) graded using Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0)

Outcome Time Frame:

21 days

Safety Issue:


Principal Investigator

Farhad Ravandi-Kashani

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

December 2005

Completion Date:

Related Keywords:

  • Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
  • Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
  • Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
  • Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
  • Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
  • Blastic Phase Chronic Myelogenous Leukemia
  • de Novo Myelodysplastic Syndromes
  • Previously Treated Myelodysplastic Syndromes
  • Recurrent Adult Acute Lymphoblastic Leukemia
  • Recurrent Adult Acute Myeloid Leukemia
  • Refractory Chronic Lymphocytic Leukemia
  • Relapsing Chronic Myelogenous Leukemia
  • Secondary Acute Myeloid Leukemia
  • Secondary Myelodysplastic Syndromes
  • Congenital Abnormalities
  • Blast Crisis
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Myelodysplastic Syndromes
  • Preleukemia



M D Anderson Cancer Center Houston, Texas  77030