DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



CMC-544 and Allogeneic Transplantation for CD22 Positive-Lymphoid Malignancies

Information source: M.D. Anderson Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lymphoma; Leukemia

Intervention: CMC-544 (Drug); Fludarabine (Drug); Bendamustine (Drug); Rituximab (Drug); Allogeneic Stem Cell Transplantation (Procedure); Thymoglobulin (Drug); Tacrolimus (Drug); Methotrexate (Drug); G-CSF (Drug)

Phase: Phase 1/Phase 2

Status: Recruiting

Sponsored by: M.D. Anderson Cancer Center

Official(s) and/or principal investigator(s):
Issa F. Khouri, MD, BS, Principal Investigator, Affiliation: M.D. Anderson Cancer Center

Overall contact:
Issa F. Khouri, MD, BS, Phone: 713-792-8750

Summary

The goal of this clinical research study is to learn which dose level of inotuzumab ozogamicin (CMC-544) work best when given with fludarabine and bendamustine, with or without rituximab, before a stem cell transplant. The safety of this treatment will also be studied. Fludarabine, bendamustine, and rituximab are commonly given before stem cell transplants. These drugs are designed to kill cancerous cells and suppress your immune system in order to lower the risk of stem cell transplant rejection. Inotuzumab ozogamicin is designed to kill cancerous cells and reduce the risk of the cancer coming back.

Clinical Details

Official title: Anti-CD22 Immunoconjugate Inotuzumab Ozogamicin (CMC-544) Added to Fludarabine, Bendamustine and Rituximab and Allogeneic Transplantation for CD22 Positive-Lymphoid Malignancies

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

Primary outcome: Maximum Tolerated Dose (MTD) of Inotuzumab Ozogamicin (CMC-544)

Secondary outcome: Overall Survival

Detailed description: Study Drug Administration: The dose of inotuzumab ozogamicin you receive will depend on when you joined this study. The first group of 2 participants will receive the lowest dose level of inotuzumab ozogamicin. Each new group will receive a higher dose of inotuzumab ozogamicin than the group before it, if no intolerable side effects were seen. Three (3) dose levels will be tested. For a stem cell transplant, the days before you receive your stem cells are called minus days. The day you receive the stem cells is called Day 0. The days after you receive the stem cells are called plus days.

On Day - 13, you will receive inotuzumab ozogamicin by vein over 1 hour.

On Day - 6, you will be admitted to the hospital and given fluids by vein to hydrate you. If

you have a CD20-positive cancer, you will receive rituximab by vein over 4-6 hours.

On Days - 5, -4- and -3, you will receive fludarabine and bendamustine by vein over 1 hour.

On Days - 2 and -1, if you will be receiving a matched unrelated donor's (MUD) stem cells,

you will receive ATG by vein over 3-4 hours. If you will be receiving a related donor's stem cells, you will "rest" (you will not receive chemotherapy drugs). ATG is given to suppress the immune system.

Beginning on Day - 2, you will receive tacrolimus as a continuous (nonstop) infusion until

you are able to take it by mouth. Tacrolimus is given to help prevent transplant rejection. On Day 0, you will receive the stem cell transplant by vein. On Days +1 and +8, if you have a CD20 positive cancer, you will receive rituximab by vein over 4-6 hours. On Days +1, +3, and +6, you will receive methotrexate by vein over 30 minutes. Methotrexate is given to help prevent graft versus host disease (GVHD). On Day +11, if you received a transplant from a MUD, you will receive methotrexate by vein over about 30 minutes. When you are able to take tacrolimus by mouth, you will take it once or twice a day for about 6 months and then your doctor will tell you how to taper it off (gradually stop taking it). You will receive filgrastim as an injection under the skin 1 time a day, starting 1 week after the transplant, until your blood cell levels return to normal. Filgrastim is designed to help with the growth of white blood cells. If the disease does not respond to treatment or gets worse, you will receive rituximab and a donor lymphocyte infusion containing T-cells by vein over 10-30 minutes. You will be given standard drugs to help decrease the risk of side effects. You may ask the study staff for information about how the drugs are given and their risks. Study Visits:

Before Day - 13:

- Blood (about 4 tablespoons) will be drawn for routine tests, to test for infectious

diseases, such as HIV and hepatitis, and to check the status of the disease.

- You will have a bone marrow aspiration and biopsy to check the status of the disease.

To collect a bone marrow aspiration/biopsy, an area of the hip or other site is numbed with anesthetic, and a small amount of bone marrow and bone is withdrawn through a large needle.

- You will have a chest x-ray.

- You will have a computed tomography (CT) scan of your neck, chest, abdomen, and pelvis.

- If your doctor thinks it is needed, you will have positron emission tomography (PET)

scan.

- If you have had Gilbert's Disease, you will have an abdominal ultrasound.

As part of standard care, you will remain in the hospital for about 3-4 weeks after the transplant. After you are sent home from the hospital, you must remain in the Houston area to be checked for infections and other transplant side effects until about 3 months after transplant. During this time, you will return to the clinic at least 1 time each week. The following tests and procedures will be performed:

- You will be asked about how you are feeling and about any side effects you may be

having.

- Blood (about 2 teaspoons) will be drawn for routine tests.

About 1, 3, 6, and 12 months after transplant and, if your doctor thinks it is needed, at Years 2 and 3:

- You will have a physical exam, including measurement of your weight.

- You will be asked about how you are feeling and about any side effects you may be

having and drugs you may be taking.

- Blood (about 2 teaspoons) will be drawn for routine tests, to check the status of the

disease, and to learn how the transplant has taken.

- If your doctor thinks it is needed, you will have a bone marrow aspiration and biopsy

to check the status of the disease,

- You will have a CT scan of your neck, chest, abdomen, and pelvis.

- If your doctor thinks it is needed, you will have a PET scan.

Length of Study: You will be on study for up to about 3 years. You may be taken off study early if the disease gets worse, if you have any intolerable side effects, if you are unable to follow study directions, if your doctor thinks it is in your best interest, if the study is stopped, or if you choose to leave the study early. You should talk to the study doctor if you want to leave the study early. If you are taken off study early, you still may need to return for routine post-transplant follow-up visits, if your transplant doctor decides it is needed. If you are thinking about dropping out of this study, please tell the study doctor. The doctor can tell you about the effects of stopping treatment. You and the doctor can talk about what follow-up care and testing would help you the most. If you leave the study, your test results and information cannot be removed from the study records. This is an investigational study. Inotuzumab ozogamicin is not FDA approved or commercially available. It is currently being used for research purposes only. All other drugs given on this study are FDA approved and commercially available. Up to 30 patients will take part in this study. All will be enrolled at MD Anderson.

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Age 18 to 70 years of age. 2. Patients with B-cell hematological malignancies who are eligible for allogeneic transplantation. 3. Patients must have a fully-matched sibling donor or a matched unrelated donor identified. 4. Performance score of at least 80% by Karnofsky or 0 to 2 ECOG. 5. Left ventricular EF >/= 45% with no uncontrolled arrhythmias or symptomatic heart disease. 6. FEV1, FVC >/= 50% and corrected DLCO >/= 50%. 7. Serum creatinine <1. 6 mg/dL. Serum bilirubin < 2 mg/dL upper limit of normal (unless due to Gilbert's Disease; patient with this disease should have a right upper quadrant ultrasound evaluation before treatment). 8. SGPT < 2 X upper limit of normal. 9. Men and women of reproductive potential must agree to follow accepted birth control methods (i. e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study. 10. Negative Beta HCG test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization) or currently breast-feeding. Pregnancy testing is not required for post-menopausal or surgically sterilized women. Exclusion Criteria: 1. Patient with active CNS involvement. 2. Known infection with HIV, HTLV-I, Hepatitis B, or Hepatitis C. 3. Patients with other malignancies diagnosed within 2 years prior to study registration. Skin squamous or basal cell carcinoma are exceptions. 4. Active bacterial, viral or fungal infections. 5. History of stroke within 6 months. 6. History of biliary colic attack. 7. A prior autologous transplant within 3 months of study entry or allogeneic stem cell transplant. 8. Serious medical or psychiatric illness likely to interfere with participation in this clinical study. 9. Patient has received other investigational drugs within 3 weeks before study registration. 10. Serious nonmalignant disease which, in the opinion of the investigator would compromise protocol objectives. 11. Prior exposure to CMC-544 within past 6 months. 12. Established refractoriness to CMC-544.

Locations and Contacts

Issa F. Khouri, MD, BS, Phone: 713-792-8750

University of Texas MD Anderson Cancer Center, Houston, Texas 77030, United States; Recruiting
Additional Information

University of Texas MD Anderson Cancer Center Website

Starting date: October 2012
Last updated: June 4, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017