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A Phase 1, Multi-Center, Open-Label, Dose-Escalation, Pharmacodynamic Study of Intravenously Administered CNF1010 (17-(Allylamino)-17-demethoxy-geldanamycin [17-AAG]) in Patients With ZAP-70 Positive B-Cell Chronic Lymphocytic Leukemia (CLL)

Phase 1
18 Years
Not Enrolling
Chronic Lymphocytic Leukemia

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Trial Information

A Phase 1, Multi-Center, Open-Label, Dose-Escalation, Pharmacodynamic Study of Intravenously Administered CNF1010 (17-(Allylamino)-17-demethoxy-geldanamycin [17-AAG]) in Patients With ZAP-70 Positive B-Cell Chronic Lymphocytic Leukemia (CLL)


Inclusion Criteria:

1. Diagnosis of B-cell CLL including

- Lymphocytosis of >=5,000 monoclonal B-cells/microliter co-expressing >= one
B-cell marker (CD19, CD20, or CD23) and CD5 in peripheral blood AND

- <= 55% prolymphocytes AND

- Bone marrow with >=30% mononuclear cells being lymphocytes

2. ZAP-70 positive CLL

3. Intermediate or High risk, poor prognosis CLL refractory to fludarabine-based therapy
as defined by one of the following:

- Disease progression following 2 cycles of fludarabine OR

- Failure to achieve PR or CR after at least 2 cycles OR

- No response to treatment or stable disease after at least 2 cycles of
fludarabine OR

- Disease progression after chemotherapy treatment after fludarabine-based therapy


ยท CLL patients intolerant to fludarabine-based therapy. [Intolerance is defined as
the development of any serious medical condition occurring after exposure to
fludarabine that would restrict further use of the agent as treatment for the
patient's CLL (i.e., autoimmune hemolytic anemia, myelosuppression,

4. Indication for treatment as defined by the NCI Working Group Guidelines

5. Laboratory parameters as follows:

- Hemoglobin >=10 g/dL (may be post-transfusion); platelet count >=50 x103/mm3

- T. Bili <2 x ULN and ALT and AST <2 x ULN

- Creatinine <=2 x ULN

6. ECOG Performance Score <=2

7. For patients of child-producing potential, use of effective contraceptive methods
during the study and for 1 month following treatment

Key Exclusion Criteria:

1. Pregnant or nursing women

2. Class III or IV cardiac disease defined by the New York Heart Association Functional
Classification and/or left ventricular ejection fraction <40%

3. History of prior radiation that potentially included the heart in the field.

4. History of myocardial infarction or active ischemic heart disease within 6 months of
study entry

5. History of arrhythmia (including atrial fibrillation, multifocal premature
ventricular contractions, ventricular bigeminy or trigeminy, ventricular tachycardia
or a requirement for antiarrhythmics (including digoxin)

6. Baseline QTc >=450 msec for men and >= 470 msec for women in the absence of
correctable electrolyte imbalance

7. Poorly controlled angina

8. Congenital long QT syndrome or first-degree relative with unexplained sudden death
<40 years of age

9. Presence of left bundle branch block

10. Treatment with chemotherapy, monoclonal antibody or radiotherapy within 28 days of
study entry

11. Severe or debilitating pulmonary disease

12. Participation in any investigational drug study within 28 days prior to CNF1010
administration. (Patient must have recovered from all acute effects of previously
administered investigational agents)

13. Presence of active malignancy with the exception of basal cell carcinoma

14. Active symptomatic fungal, bacterial and/or viral infection including active HIV or
viral (A, B or C) hepatitis

15. Known allergy to soy

16. Requirement for concomitant therapy with drugs that alter metabolism by cytochrome
P450 3A4 except low-dose warfarin for implanted device patency

17. Requirement for concomitant therapy with drugs that prolong or may prolong QTc

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The minimal biologically active dose (MBAD)


United States: Food and Drug Administration

Study ID:




Start Date:

May 2005

Completion Date:

May 2007

Related Keywords:

  • Chronic Lymphocytic Leukemia
  • Chronic lymphocytic leukemia
  • CLL
  • ZAP-70
  • Hsp90 inhibitor
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid



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