MDACC Study Summary ID03-0124

Study Summary
No. ID03-0124:.......Leukemia......Maria E. Cabanillas......Endocrine Neoplasia & Hormonal Disorders

Study Summary Title



Study Summary Number:	ID03-0124

Study Title:	A Randomized, Double Blinded Study of Actonel for the Prevention of Bone Loss in Patients Receiving High Dose Corticosteroids for the Treatment of Acute Lymphocytic Leukemia (ALL) and Lymphoblastic Lymphoma (LL).

Physician

New Patient Referral



Name:	Maria E. Cabanillas	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Endocrine Neoplasia & Hormonal Disorders	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-563-0764 Contact us about clinical trials

General Information



Disease Group:	Leukemia	Supported By:	N/A

Phase of Study:	Phase III	Return Visit:	Patients will return to MDACC for bone mineral densities at 6, 12, and 24 months.

Treatment Agents:	Actonel	Home Care:	Medication will be self-administered at home.

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	There is no need for hospitalization for this study, however, the patients will continue to receive Actonel during their hospital stay for routine chemotherapy.


Description/ Intervention:	The goal of this clinical research study is to learn if Actonel (risedronate) can help to prevent the development of osteoporosis (brittle and weak bones) caused by the steroid medication used to treat leukemia. The safety of this treatment in patients with ALL or LL will also be studied.

Study Objectives / Outcomes

Primary: To determine whether the use of Actonel decreases the amount of bone loss in Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma (LL) patients receiving chemotherapy with high dose steroids.

Secondary: To determine the CR (complete remission) rate in ALL and LL.

Study Status Information



Study Activation / Registration Date:	02/06/2004

IRB Review and Approval Date:	05/07/2003

Study Type:	Therapeutic

Recruitment Status:	Open

Projected Accrual:	80

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) Age greater than or equal to 18 years

2) Newly diagnosed ALL or LL receiving chemotherapy with augmented BFM, Hyper-CVAD or any variant of hyper-CVAD.

3) Female patients of childbearing potential (i.e. no hysterectomy, no loss of menses for 12 consecutive months), must be willing to use contraception.

4) Negative pregnancy test in female patients.

5) Patients must be enrolled within 6 weeks of starting induction chemotherapy.

Exclusion Criteria:

1) Hypocalcemia of less than 8.4 (corrected to account for the albumin level, [see Appendix E for formula])

2) Hypersensitivity to risedronate or other bisphosphonates

3) Inability to sit or stand upright for at least 30 minutes

4) Bone density T-score of -2.5 S.D or less.

5) Renal insufficiency (calculated creatinine clearance <30cc/min,[see Appendix F for formula])

6) Patients with a 25-hydroxyvitamin D concentration of less than 20 ng/ml and evidence of osteomalacia (low ionized calcium and high intact PTH).

7) Concomitant use of bisphosphonates, calcitonin, anabolic steroids, or fluoride.

8) Corrected calcium above 10.2, due to a cause not related to leukemia/lymphoma (i.e. hyperparathyroidism, multiple myeloma).

Links

Registration Number: NCT00452439
Study Information on Clinical Trials Registry (clinicaltrials.gov)