MDACC Study Summary 2005-0749 (Archived)

Study Summary
No. 2005-0749:.......Lymphoma......Michelle A. Fanale......Lymphoma/Myeloma

Study Summary Title



Study Summary Number:	2005-0749

Study Title:	An Open Label Dose and Schedule Finding Trial to Evaluate the Safety and Efficacy of AMG 531 for Treatment of Severe Thrombocytopenia Due to Multi-Cycle Chemotherapy in Adult Subjects with Lymphoma

Physician

New Patient Referral



Name:	Michelle A. Fanale	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Lymphoma/Myeloma	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-2860 Contact us about clinical trials

General Information



Disease Group:	Lymphoma	Supported By:	N/A

Phase of Study:	Phase I/Phase II	Return Visit:	There are 13 study visits during the screening cycle(s) and 12 study visits during the treatment cycle(s).

Treatment Agents:	AMG 531	Home Care:	None

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	NA


Description/ Intervention:	The purpose of this clinical research study is to find a safe dose and schedule of AMG 531 that is appropriate for treatment of low platelet counts caused by chemotherapy, in patients with lymphoma who are receiving multi-cycle chemotherapy.

Study Objectives / Outcomes

Primary:

To identify a safe dose (and schedule) of AMG 531 that is appropriate for treatment of chemotherapy induced thrombocytopenia (CIT) in subjects with aggressive lymphomas (Non-Hodgkin's and Hodgkin lymphomas) receiving multi-cycle chemotherapy.

Secondary:

To evaluate the overall efficacy of AMG 531 in subjects with severe thrombocytopenia due to multi-cycle chemotherapy.

Study Status Information



Study Activation / Registration Date:	05/25/2006

IRB Review and Approval Date:	01/18/2006

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Terminated

Projected Accrual:	50-73

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Subjects with histologically confirmed Hodgkins, and Non-Hodgkins Lymphoma (NHL) who are receiving the allowed chemotherapy regimens.

2) Subjects who are receiving Q14, Q21, or Q28 day CHOP, ICE, ESHAP, or DHAP chemotherapy; with or without Rituximab.

3) Subjects must have experienced CTC grade 3 or 4 thrombocytopenia (platelet count < 50 x 10^9/L) as a result of the chemotherapy administered in the cycle immediately preceding study entry.

4) Subjects must be able to receive the same chemotherapy regimen (same agents, doses and schedules) during the treatment study cycle as was received during the prior qualifying cycle (dose delay is acceptable for platelet count to recover to > 100 x 10^9/L).

5) Subjects must be >/= 18 years of age.

6) Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at the time of screening

7) Subjects must have had adequate bone marrow function on the day of initiation of the on study chemotherapy defined as: absolute neutrophil count >/= 1x 10^9/L, hemoglobin >/= 9.5 g/dL, and platelet count > 100 x 10^9/L.

8) Subjects must have a serum creatinine concentration </= 2 mg/dl (</= 176.8 micromol/L).

9) Subjects must have adequate liver function, as evidenced by a serum bilirubin </= 1.5 times the upper limit of normal (except for subjects with a confirmed diagnosis of Gilbert's syndrome, normal liver function will be defined as an ALT and AST </= 3 times the upper limit of normal.)

10) Before any study-specific procedure, the appropriate written informed consent must be obtained.

Exclusion Criteria:

1) Subjects who have received more than one prior relapse chemotherapy regimen.

2) Subjects who have received a marrow or peripheral blood stem cell infusion.

3) Subject who have sepsis, disseminated coagulation or any other condition (eg ITP, TTP) that may have exacerbated thrombocytopenia during the prior cycle of chemotherapy

4) Significant bleeding (CTC grade 3 or 4).

5) Subjects with a history of thromboembolic disease.

6) Subjects who are identified by clinical history and/or serological testing to have either acute or chronic hepatitis B or C infection or to be HIV positive.

7) The use of any nitrosourea (BCNU, CCNU) or mitomycin-C within 6 weeks of study entry.

8) Subjects who have received any thrombocytopenic growth factor or related substance.

9) Subject who have received any experimental therapy within 4 weeks prior to study entry.

10) Subject of child-bearing potential is evidently pregnant (eg, positive HCG test) or is breast feeding.

11) Subject is not using adequate contraceptive precautions.

12) Subject has a known hypersensitivity to any recombinant E coli-derived product.

13) Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures.

Links

Registration Number: NCT00283439
Study Information on Clinical Trials Registry (clinicaltrials.gov)