Acute Myelogenous LeukemiaPhase 2NCT00683046

T-Cell Depleted Allogeneic Stem Cell Transplantation for Patients With Hematologic Malignancies

A Phase 2 study testing Fludarabine, Melphalan and Stem cells in people with Acute Myelogenous Leukemia and Lymphoid Leukemia, run by University of Chicago at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Objectives: 1. To evaluate disease free survival after Campath 1H-based in vivo T-cell depletion and non-myelo-ablative ablative stem cell transplantation in patients with hematologic malignancies. 2. Read more about this study

Who is it for?: Ages Up to 100 years
Conditions the study is for: Acute Myelogenous Leukemia, Lymphoid Leukemia, Chronic Myelogenous Leukemia
What is being tested?: Fludarabine, Melphalan and Stem cells
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 204 participants
Where: 1 siteUnited States
Study dates: Nov 2001to Dec 2014
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Up to 100 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Zubrod performance status 2 (See Appendix B).
Life expectancy is not severely limited by concomitant illness.
Adequate cardiac and pulmonary function. Patients with decreased LVEF or PFTS will be evaluated by cardiology or pulmonary prior to enrollment on this protocol.
Serum creatinine <1.5 mg/dL or Creatinine Clearance >50 ml/min .
Serum bilirubin 2.0 mg/dl, SGPT <3 x upper limit of normal
No evidence of chronic active hepatitis or cirrhosis.

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HIV-negative
Patient is not pregnant
Patient or guardian able to sign informed consent.

Who cannot join

Trial locations and contacts

1 site in 1 country.

United States1 site

The University of Chicago
Chicago, Illinois, 60637

Other trials in United States

About this study

Objectives:

To evaluate disease free survival after Campath 1H-based in vivo T-cell depletion and non-myelo-ablative ablative stem cell transplantation in patients with hematologic malignancies.
To evaluate the incidence and severity of acute and chronic GVHD after Campath 1H-based in vivo T-cell depletion, in patients with hematologic malignancies undergoing non-myelo-ablative stem cell transplantation.
To evaluate engraftment and chimerism after Campath 1H-based in vivo T-cell depletion and non-myelo-ablative ablative stem cell transplantation in patients with hematologic malignancies.

Conditions: Acute Myelogenous Leukemia, Lymphoid Leukemia, Chronic Myelogenous Leukemia, Malignant Lymphoma, Hodgkin's Disease, Chronic Lymphocytic Leukemia
Being tested: Fludarabine, Melphalan, Stem cells, Campath
Keywords: Relapsed or refractory acute myelogenous or lymphoid leukemia., Acute myeloid or lymphocytic leukemia in first remission at high-risk for recurrence.Chronic myelogenous leukemia in accelerated phase or blast-crisis., Chronic myelogenous leukemia in chronic phase, Chronic myelogenous leukemia in accelerated phase or blast-crisis, Recurrent or refractory malignant lymphoma or Hodgkin's disease., Chronic lymphocytic leukemia, relapsed or with poor prognostic features., Myeloproliferative disorder (polycythemia vera, myelofibrosis) with poor prognostic features., Severe aplastic anemia after failure of immunosuppressive therapy., Myelodysplastic syndromes (including PNH), Multiple myeloma at high risk for disease recurrence.
Medical subject headings: Leukemia, Myeloid, Acute, Leukemia, Lymphoid, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Lymphoma, Hodgkin Disease, Leukemia, Lymphocytic, Chronic, B-Cell, Myeloproliferative Disorders, Anemia, Aplastic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FludarabineDrug
Fludarabine 30 mg/m2 intravenously daily at the same time over 30 minutes on days -7,-6,-5,4,-3,.
MelphalanDrug
Melphalan 140 mg/m2 IV on day -2.
Stem cellsDrug
Stem cell infusion on day 0.
CampathDrug
Campath, 20 mg IV on day -7, 6, -5, -4, and -3.

Study groups in NCT00683046
Study group	Role	What they receive
Drug Intervention	Experimental	Not described Receives: Drug: Fludarabine; Drug: Melphalan; Drug: Stem cells; Drug: Campath

What is being measured

The primary outcome is the main question the study is designed to answer.

Median Disease-free Survival
All patients were administered the following drugs;
1. Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3
2. Melphalan 140mg/m2 IV on day -2
3. Stem cell infusion on day 0
4. Campath 20mg IV on day -7,-6,-5,-4, and -3
Measured: Patients evaluated continuously with disease specific re-evaluation at day 30, 3 months, 6 months, 1 year, and as indicated thereafter up to 10 years

Secondary outcomes (1)

Median Overall Survival
All patients were administered the following drugs;
1. Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3
2. Melphalan 140mg/m2 IV on day -2
3. Stem cell infusion on day 0
4. Campath 20mg IV on day -7,-6,-5,-4, and -3
Measured: Patients evaluated continuously with disease specific re-evaluation at day 30, 3 months, 6 months, 1 year, and as indicated thereafter up to 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2001Dec 2014

First posted23 May 2008 (estimated)
Study startNov 2001
Primary completionDec 2014
Study completionDec 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Acute Myelogenous LeukemiaStudies of the same condition, open and under way.
More trials run by University of ChicagoThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 204 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00683046
Sponsor's protocol ID: 11300A
Status last verified: Oct 2016
First submitted: 21 May 2008
Last updated: 22 Nov 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Acute Myelogenous Leukemia trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: T-Cell Depleted Allogeneic Stem Cell Transplantation for Patients With Hematologic Malignancies
ClinicalTrials.gov ID: NCT00683046
Acronym / sponsor ID: 11300A
Conditions: Acute Myelogenous Leukemia, Lymphoid Leukemia, Chronic Myelogenous Leukemia, Malignant Lymphoma, Hodgkin's Disease, Chronic Lymphocytic Leukemia
Keywords: Relapsed or refractory acute myelogenous or lymphoid leukemia., Acute myeloid or lymphocytic leukemia in first remission at high-risk for recurrence.Chronic myelogenous leukemia in accelerated phase or blast-crisis., Chronic myelogenous leukemia in chronic phase, Chronic myelogenous leukemia in accelerated phase or blast-crisis, Recurrent or refractory malignant lymphoma or Hodgkin's disease., Chronic lymphocytic leukemia, relapsed or with poor prognostic features., Myeloproliferative disorder (polycythemia vera, myelofibrosis) with poor prognostic features., Severe aplastic anemia after failure of immunosuppressive therapy.
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 204 participants (actual)
Lead sponsor: University of ChicagoUniversity, hospital or other
Study start: Nov 2001
Primary completion: Dec 2014 (actual)
Study completion: Dec 2014 (actual)
First posted: 23 May 2008 (estimated)
Results: Posted 31 Mar 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Objectives:

To evaluate disease free survival after Campath 1H-based in vivo T-cell depletion and non-myelo-ablative ablative stem cell transplantation in patients with hematologic malignancies.
To evaluate the incidence and severity of acute and chronic GVHD after Campath 1H-based in vivo T-cell depletion, in patients with hematologic malignancies undergoing non-myelo-ablative stem cell transplantation.
To evaluate engraftment and chimerism after Campath 1H-based in vivo T-cell depletion and non-myelo-ablative ablative stem cell transplantation in patients with hematologic malignancies.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Drug Intervention	Experimental	Drug: Fludarabine, Drug: Melphalan, Drug: Stem cells, Drug: Campath

Who may qualify

Ages: Up to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (9 listed)

Zubrod performance status 2 (See Appendix B).
Life expectancy is not severely limited by concomitant illness.
Adequate cardiac and pulmonary function. Patients with decreased LVEF or PFTS will be evaluated by cardiology or pulmonary prior to enrollment on this protocol.
Serum creatinine <1.5 mg/dL or Creatinine Clearance >50 ml/min .
Serum bilirubin 2.0 mg/dl, SGPT <3 x upper limit of normal

Key exclusion criteria (1 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FludarabineFludarabine 30 mg/m2 intravenously daily at the same time over 30 minutes on days -7,-6,-5,4,-3,.	Drug	Drug Intervention
MelphalanMelphalan 140 mg/m2 IV on day -2.	Drug	Drug Intervention
Stem cellsStem cell infusion on day 0.	Drug	Drug Intervention
CampathCampath, 20 mg IV on day -7, 6, -5, -4, and -3.	Drug	Drug Intervention

Primary outcome

Median Disease-free Survival
Time frame: Patients evaluated continuously with disease specific re-evaluation at day 30, 3 months, 6 months, 1 year, and as indicated thereafter up to 10 years
All patients were administered the following drugs; 1. Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3 2. Melphalan 140mg/m2 IV on day -2 3. Stem cell infusion on day 0 4. Campath 20mg IV on day -7,-6,-5,-4, and -3

1 secondary outcome

Median Overall Survival
Time frame: Patients evaluated continuously with disease specific re-evaluation at day 30, 3 months, 6 months, 1 year, and as indicated thereafter up to 10 years

Results and safety

Results posted to the registry on 31 Mar 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
T-cell Depleted Allogeneic Stem Cell Transplantation	204	204

Primary outcome: Median Disease-free Survival

Time frame: Patients evaluated continuously with disease specific re-evaluation at day 30, 3 months, 6 months, 1 year, and as indicated thereafter up to 10 years. Median (95% Confidence Interval). Unit: Days

Measure	T-cell Depleted Allogeneic Stem Cell Transplantation n = 204
Value	333 (253 to 386)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 180 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
T-cell Depleted Allogeneic Stem Cell Transplantation	69 of 204 (33.8%)	0 of 204 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Andrew Artz, MD principal investigator

University of Chicago

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fludarabine, Melphalan and Stem cells in people with Acute Myelogenous Leukemia and Lymphoid Leukemia, run by University of Chicago at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Median Disease-free Survival (time frame: Patients evaluated continuously with disease specific re-evaluation at day 30, 3 months, 6 months, 1 year, and as indicated thereafter up to 10 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00683046.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2016.