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


Phase 1/Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Lymphoma, Leukemia

Thank you

Trial Information

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


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.


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 * 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 central nervous system (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 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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Description:

The MTD is defined as the highest dose for which the probability of toxicity is closest to 30%. The dose-limiting toxicity (DLT) is defined as grade III or IV renal, hepatic, intestinal, neurologic, pulmonary or cardiac adverse events, as well as any graft failure or treatment-related death at any time from first CMC-544 administration (D-13) through 30 days post transplant (D30).

Outcome Time Frame:

1 month

Safety Issue:

Yes

Principal Investigator

Issa F. Khouri, MD, BS

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

2012-0265

NCT ID:

NCT01664910

Start Date:

October 2012

Completion Date:

Related Keywords:

  • Lymphoma
  • Leukemia
  • Lymphoma
  • CD22 Positive-Lymphoid Malignancies
  • Leukemia
  • Allogeneic stem cell transplant
  • CMC-544
  • Inotuzumab Ozogamicin
  • Fludarabine
  • Fludarabine Phosphate
  • Fludara
  • Bendamustine
  • Bendamustine Hydrochloride
  • Bendamustine HCL
  • CEP-18083
  • SDX105
  • Treanda
  • G-CSF
  • Filgrastim
  • Neupogen
  • Methotrexate
  • Rituximab
  • Rituxan
  • Thymoglobulin
  • ATG
  • Antithymocyte Globulin
  • Tacrolimus
  • Prograf
  • Neoplasms
  • Leukemia
  • Lymphoma

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030