Acute Myeloid LeukemiaIM-TMINCT00988013
Intensity Modulated Total Marrow Irradiation (IM-TMI) for Advanced Hematologic Malignancies
A study testing IM-TMI (3Gy), IM-TMI (6Gy) and IM-TMI (9Gy) in people with Acute Myeloid Leukemia and Lymphoblastic Leukemia, run by University of Illinois Chicago at 1 site in United States.
Trial summary
This is a phase I study using Intensity Modulated Total Marrow Irradiation (IM-TMI) in addition to a chemotherapy regimen in preparation for an allogeneic stem cell transplant for advanced hematologic malignancies such as acute myeloid or lymphoblastic leukemia, high grade non Hodgkin's or Hodgkin's lymphoma, chronic… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Acute Myeloid Leukemia, Lymphoblastic Leukemia, Acute Leukemia
- What is being tested?
- IM-TMI (3Gy), IM-TMI (6Gy) and IM-TMI (9Gy)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Feb 2016
- Phase
- Interventional
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with the following diseases:
- Acute myeloid or lymphoblastic leukemia in first complete remission if poor prognosis documented by failure to response after initial induction chemotherapy, or cytogenetic, or molecular studies.
- Acute leukemia in greater/equal second remission, or partial remission after chemotherapy.
- High grade non Hodgkin's or Hodgkin's lymphoma with marrow involvement resistant/ relapsed after second line therapy including high dose chemotherapy and autologous SCT.
- CML in advanced or blastic phase.
- Plasma cell leukemia.
Show all 11Show fewer
- Age 18-60 years.
- Karnofsky performance status of 70
- Adequate cardiac and pulmonary function. Patients with decreased LVEF less than/equal to 40% or DLCO less than/equal to 50% of predicted will require clearance from cardiology or pulmonary services, respectively, prior to enrollment on this protocol.
- Serum creatinine less than/equal to 1.5 mg/dL or Creatinine Clearance greater than/equal to 50 ml/min .
- Serum bilirubin 2.0 mg/dl, SGPT less than/equal to 3 times the upper limit of normal
Who cannot join
- Life expectancy is severely limited by concomitant illness.
- Evidence of chronic active hepatitis or cirrhosis
- HIV-positive
- Patient is pregnant
- Patient or guardian is not able to sign informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago
Chicago, Illinois, 60612
About this study
Official title: A Phase I Study of Intensity Modulated Total Marrow Irradiation (IM-TMI) in Addition to Fludarabine/Busulfan Conditioning for Allogeneic Transplantation for Advanced Hematologic Malignancies
This is a phase I study using Intensity Modulated Total Marrow Irradiation (IM-TMI) in addition to a chemotherapy regimen in preparation for an allogeneic stem cell transplant for advanced hematologic malignancies such as acute myeloid or lymphoblastic leukemia, high grade non Hodgkin's or Hodgkin's lymphoma, chronic myelogenous leukemia, and plasma cell leukemia. Because the subjects participating in this study have a disease that is severe and has a high risk of relapse even after transplant, the investigators propose to use a chemotherapy regimen (fludarabine/busulfan), the name for the combination of chemotherapy drugs that is given to patients prior to transplantation of the donor stem cells, along with intensity modulated radiation (IM-TMI) to the bone marrow. Total body irradiation (TBI) in conjunction with chemotherapy is a standard of care as a pre-conditioning regimen prior to bone marrow transplant (BMT) in patients with hematologic malignancies. However, TBI can cause severe side effects due to irradiation of organs such as the lenses of the eye, whole brain, lungs, liver, kidneys, heart, small bowel and oral cavity. IM-TMI allows for the delivery of adequate doses of radiation to the bone marrow while sparing other organs and therefore limiting radiation side effects. The irradiation, along with receiving the chemotherapy drugs will suppress the subject's immune system and kill off tumor cells, but will also intensify the effect of the conditioning regimen thus allowing the bone marrow transplantation to have a greater chance of being successful.
No investigational drugs are used in this study. The investigational part of this study is the use of intensity modulated total marrow irradiation instead of conventional radiation. IMTMI can deliver 99% of the prescribed treatment to the targeted bones and reduce the doses of radiation to surrounding organs, as received in conventional TBI, by 29% to 65%.
- Conditions
- Acute Myeloid Leukemia, Lymphoblastic Leukemia, Acute Leukemia, Non Hodgkins Lymphoma, Chronic Myeloid Leukemia
- Being tested
- IM-TMI (3Gy), IM-TMI (6Gy), IM-TMI (9Gy), IM-TMI (12Gy)
- Keywords
- total marrow irradiation, intensity modulated radiation, leukemia, hematologic diseases
- Medical subject headings
- Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Non-Hodgkin, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Leukemia, Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IM-TMI (3Gy)Radiation
Patients will receive 3Gy per day for 1 day.
IM-TMI (6Gy)Radiation
Patients will receive 3Gy per day for 2 days.
IM-TMI (9Gy)Radiation
Patients will receive 3Gy per day for 3 days.
IM-TMI (12Gy)Radiation
Patients will receive 3Gy per day for 4 days.
| Study group | Role | What they receive |
|---|---|---|
| IM-TMI (3Gy) | Experimental | Patients will receive 3Gy per day for 1 day (total of 3Gy). Receives: Radiation: IM-TMI (3Gy) |
| IM-TMI (6Gy) | Experimental | Patients will receive 3Gy per day for 2 days (for a total of 6Gy). Receives: Radiation: IM-TMI (6Gy) |
| IM-TMI (9Gy) | Experimental | Patients will receive 3Gy per day for 3 days (for a total of 9Gy). Receives: Radiation: IM-TMI (9Gy) |
| IM-TMI (12Gy) | Experimental | Patients will receive 3Gy per day for 4 days (for a total of 12Gy). Receives: Radiation: IM-TMI (12Gy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Grade 4 TMI Toxicity
Measured: 1 year post-transplant
Number of Participants With 1 Year Mortality Unrelated to TMI
Measured: 1 year post-transplant
Secondary outcomes (1)
Time to Neutrophil and Platelet Engraftment in Patients With Hematologic Malignancies
Measured: Up to 100 days post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2009 (estimated)
- Study startSep 2009
- Primary completionFeb 2016
- Study completionFeb 2016
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Dose escalation of total marrow irradiation prior to stem cell transplantation
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Damiano Rondelli, MD, University of Illinois Chicago
- Investigators
- Damiano Rondelli, MD, Study chair, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00988013
- Sponsor's protocol ID
- 2009-0251
- Acronym
- IM-TMI
- Status last verified
- May 2021
- First submitted
- 30 Sep 2009
- Last updated
- 14 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Patel P, Aydogan B, Koshy M, Mahmud D, Oh A, Saraf SL, Quigley JG, Khan I, Sweiss K, Mahmud N, Peace DJ, DeMasi V, Awan AM, Weichselbaum RR, Rondelli D. Combination of linear accelerator-based intensity-modulated total marrow irradiation and myeloablative fludarabine/busulfan: a phase I study. Biol Blood Marrow Transplant. 2014 Dec;20(12):2034-41. doi: 10.1016/j.bbmt.2014.09.005. Epub 2014 Sep 16.
PubMed 25234438
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Intensity Modulated Total Marrow Irradiation (IM-TMI) in Addition to Fludarabine/Busulfan Conditioning for Allogeneic Transplantation for Advanced Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT00988013
- Acronym / sponsor ID
- IM-TMI / 2009-0251
- Conditions
- Acute Myeloid Leukemia, Lymphoblastic Leukemia, Acute Leukemia, Non Hodgkins Lymphoma, Chronic Myeloid Leukemia
- Keywords
- total marrow irradiation, intensity modulated radiation, leukemia, hematologic diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 1 Oct 2009 (estimated)
- Results
- Posted 14 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase I study using Intensity Modulated Total Marrow Irradiation (IM-TMI) in addition to a chemotherapy regimen in preparation for an allogeneic stem cell transplant for advanced hematologic malignancies such as acute myeloid or lymphoblastic leukemia, high grade non Hodgkin's or Hodgkin's lymphoma, chronic myelogenous leukemia, and plasma cell leukemia. Because the subjects participating in this study have a disease that is severe and has a high risk of relapse even after transplant, the investigators propose to use a chemotherapy regimen (fludarabine/busulfan), the name for the combination of chemotherapy drugs that is given to patients prior to transplantation of the donor stem cells, along with intensity modulated radiation (IM-TMI) to the bone marrow. Total body irradiation (TBI) in conjunction with chemotherapy is a standard of care as a pre-conditioning regimen prior to bone marrow transplant (BMT) in patients with hematologic malignancies. However, TBI can cause severe side effects due to irradiation of organs such as the lenses of the eye, whole brain, lungs, liver, kidneys, heart, small bowel and oral cavity. IM-TMI allows for the delivery of adequate doses of radiation to the bone marrow while sparing other organs and therefore limiting radiation side effects. The irradiation, along with receiving the chemotherapy drugs will suppress the subject's immune system and kill off tumor cells, but will also intensify the effect of the conditioning regimen thus allowing the bone marrow transplantation to have a greater chance of being successful.
No investigational drugs are used in this study. The investigational part of this study is the use of intensity modulated total marrow irradiation instead of conventional radiation. IMTMI can deliver 99% of the prescribed treatment to the targeted bones and reduce the doses of radiation to surrounding organs, as received in conventional TBI, by 29% to 65%.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Dose escalation of total marrow irradiation prior to stem cell transplantation
| Arm | Type | Receives |
|---|---|---|
| IM-TMI (3Gy) | Experimental | Radiation: IM-TMI (3Gy)Patients will receive 3Gy per day for 1 day (total of 3Gy). |
| IM-TMI (6Gy) | Experimental | Radiation: IM-TMI (6Gy)Patients will receive 3Gy per day for 2 days (for a total of 6Gy). |
| IM-TMI (9Gy) | Experimental | Radiation: IM-TMI (9Gy)Patients will receive 3Gy per day for 3 days (for a total of 9Gy). |
| IM-TMI (12Gy) | Experimental | Radiation: IM-TMI (12Gy)Patients will receive 3Gy per day for 4 days (for a total of 12Gy). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Patients with the following diseases:
- Age 18-60 years.
- Karnofsky performance status of 70
- Adequate cardiac and pulmonary function. Patients with decreased LVEF less than/equal to 40% or DLCO less than/equal to 50% of predicted will require clearance from cardiology or pulmonary services, respectively, prior to enrollment on this protocol.
- Serum creatinine less than/equal to 1.5 mg/dL or Creatinine Clearance greater than/equal to 50 ml/min .
Key exclusion criteria (5 listed)
- Life expectancy is severely limited by concomitant illness.
- Evidence of chronic active hepatitis or cirrhosis
- HIV-positive
- Patient is pregnant
- Patient or guardian is not able to sign informed consent.
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 |
|---|---|---|
| IM-TMI (3Gy)Patients will receive 3Gy per day for 1 day. | Radiation | IM-TMI (3Gy) |
| IM-TMI (6Gy)Patients will receive 3Gy per day for 2 days. | Radiation | IM-TMI (6Gy) |
| IM-TMI (9Gy)Patients will receive 3Gy per day for 3 days. | Radiation | IM-TMI (9Gy) |
| IM-TMI (12Gy)Patients will receive 3Gy per day for 4 days. | Radiation | IM-TMI (12Gy) |
Primary outcome
Number of Participants With Grade 4 TMI Toxicity
Time frame: 1 year post-transplant
Number of Participants With 1 Year Mortality Unrelated to TMI
Time frame: 1 year post-transplant
1 secondary outcome
Time to Neutrophil and Platelet Engraftment in Patients With Hematologic Malignancies
Time frame: Up to 100 days post-transplant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25234438Patel P, Aydogan B, Koshy M, Mahmud D, Oh A, Saraf SL, Quigley JG, Khan I, Sweiss K, Mahmud N, Peace DJ, DeMasi V, Awan AM, Weichselbaum RR, Rondelli D. Combination of linear accelerator-based intensity-modulated total marrow irradiation and myeloablative fludarabine/busulfan: a phase I study. Biol Blood Marrow Transplant. 2014 Dec;20(12):2034-41. doi: 10.1016/j.bbmt.2014.09.005. Epub 2014 Sep 16.
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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.
Damiano Rondelli, MD study chair
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IM-TMI (3Gy), IM-TMI (6Gy) and IM-TMI (9Gy) in people with Acute Myeloid Leukemia and Lymphoblastic Leukemia, run by University of Illinois 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 11 inclusion and 5 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 14 Jun 2021. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jun 2021). 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?
Number of Participants With Grade 4 TMI Toxicity (time frame: 1 year post-transplant). The study lists 2 primary outcomes in all. 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 NCT00988013, which also lists 1 linked publication.
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 14 Jun 2021.